AccessGUDID - DEVICE: OTSC System Set (04260206310037)

GUDID

Device Identifier (DI) Information

Brand Name: OTSC System Set
Version or Model: 12/3 a
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100.05
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

Device Description: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gastrointestinal endoscopic clip, long-term	A sterile clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included.

FDA Product Code

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Product Code	Product Code Name
PKL	Hemostatic Metal Clip For The Gi Tract

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101428	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: thread length 165 cm
Device Size Text, specify: depth of cap 3 mm
Device Size Text, specify: endoscope diameter 10.5 - 12 mm
Device Size Text, specify: clip type "a" has blunt teeth

Device Record Status

Public Device Record Key: 2c69f47f-be44-4afe-94a0-6a8e04d56829
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 18, 2015