AccessGUDID - DEVICE: OTSC Anchor (04260206310143)

GUDID

Device Identifier (DI) Information

Brand Name: OTSC Anchor
Version or Model: 165 cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200.10
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

Device Description: The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: needle width 12 mm / stich depth 4 mm
Device Size Text, specify: working channel diameter 3.2 mm
Device Size Text, specify: working length 165 cm

Device Record Status

Public Device Record Key: 23cc0847-bd15-474b-825f-7d4da538ef11
Public Version Date: November 03, 2022
Public Version Number: 6
DI Record Publish Date: September 16, 2016