Dermagold100 1000022

GUDID 04260484571830

The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

MTS Medical UG (haftungsbeschränkt)

Dermatological extracorporeal shock wave therapy system

Primary Device ID	04260484571830
NIH Device Record Key	8383f5b2-ee12-4479-841f-69e7c975e7b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dermagold100
Version Model Number	OW100S-US
Catalog Number	1000022
Company DUNS	342585299
Company Name	MTS Medical UG (haftungsbeschränkt)
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com
Phone	(888) 862-6162
Email	info@trtllc.com

Device Dimensions

Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	21 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260484571823 [Primary]
GS1	04260484571830 [Package] Contains: 04260484571823 Package: Box [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K231710

FDA Product Code

PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-19
Device Publish Date	2023-09-11

Devices Manufactured by MTS Medical UG (haftungsbeschränkt)

04260484571830 - Dermagold100	2023-09-19The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
04260484571830 - Dermagold100	2023-09-19 The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer w
04260484571625 - OW100S	2022-12-07 Indications for Use The OW100S (model OW100S-US) is intended for: - Relief of minor muscle aches and pains - Temporary increase
04260484571694 - VIASURE	2021-07-09 Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blo
04260484571649 - DermaGold100®	2020-04-08 The DermaGold100® is intended for treatment of diabetic footulcers
4260484573018 - MTS	2020-04-01 The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold®
04260484571618 - OrthoGold100®	2019-02-25 The OrthoGold100® is intended for the activation of connective tissue.