diagnostic FTRD Set 200.76

GUDID 04260206311072

The diagnostic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • enables a thorough pathological examination of e.g. motility disorders (e.g. Morbus Hirschsprung) • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: diagnostic FTRD (application cap with preloaded clip and integrated HF snare | endoscope sleeve, hand wheel and thread retriever | for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD)

Ovesco Endoscopy AG

Endoscopic electrosurgical full-thickness tissue biopsy/resection set

Primary Device ID	04260206311072
NIH Device Record Key	10b2fe85-ce4b-4667-8cca-9e71737e1388
Commercial Distribution Status	In Commercial Distribution
Brand Name	diagnostic FTRD Set
Version Model Number	13
Catalog Number	200.76
Company DUNS	344007369
Company Name	Ovesco Endoscopy AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com
Phone	+49707196528160
Email	service@ovesco.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206311072 [Primary]

FDA Product Code

OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2020-02-06
Device Publish Date	2018-10-02

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