AccessGUDID - DEVICE: BARS Set (04260206310983)

GUDID

Device Identifier (DI) Information

Brand Name: BARS Set
Version or Model: BARS Set
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100.60
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

Device Description: The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • 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

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241858	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
Balloon Length: 1800 Millimeter
Balloon Diameter: 20 Millimeter
Balloon Length: 1850 Millimeter
Balloon Diameter: 6 Millimeter
Guidewire Length: 3700 Millimeter
Guidewire Diameter: 0.035 Inch
Device Size Text, specify: for endoscopes with diameter of 10 - 12 mm
Device Size Text, specify: for endoscopes with a working length of 1030 - 1100 mm
Device Size Text, specify: for endoscopes with a working channel diameter of 3.7 mm

Device Record Status

Public Device Record Key: f52eb525-2137-4926-9e9c-0c3afc86d2b1
Public Version Date: December 09, 2024
Public Version Number: 1
DI Record Publish Date: November 29, 2024