D100 dermatome set 4.D100STS

GUDID 08717903490501

Humeca B.V.

Dermatome handpiece, electrically-powered

Primary Device ID	08717903490501
NIH Device Record Key	bde4e94e-42c2-49d8-8358-453eae70cfba
Commercial Distribution Status	In Commercial Distribution
Brand Name	D100 dermatome set
Version Model Number	4.D100STS
Catalog Number	4.D100STS
Company DUNS	489831498
Company Name	Humeca B.V.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Conditional
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	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717903490501 [Primary]
GS1	08717903490518 [Direct Marking]

FDA Product Code

GFD

Dermatome