AccessGUDID - DEVICE: stentfix OTSC System Set (04260206311706)

GUDID

Device Identifier (DI) Information

Brand Name: stentfix OTSC System Set
Version or Model: stentfix
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100.50
Company Name: Ovesco Endoscopy Usa, Inc.

Primary DI Number: 04260206311706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969139760 *Terms of Use

Device Description: The stentfix 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 the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61208	Gastrointestinal endoscopic clip, long-term, non-bioabsorbable	A non-bioabsorbable 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, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PKL	Hemostatic Metal Clip For The Gi Tract
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183309	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: clip type "t" has pointed teeth
Device Size Text, specify: endoscope diameter 8.5 - 11 mm
Device Size Text, specify: depth of cap 7 mm
Device Size Text, specify: thread length 165 cm

Device Record Status

Public Device Record Key: 9b4258c8-9d5e-4acb-a082-bf8c90b4e9c9
Public Version Date: September 23, 2024
Public Version Number: 1
DI Record Publish Date: September 13, 2024