AccessGUDID - DEVICE: NA (06959664902981)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: AG-5104-2300-135-16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG6.510E.4497.000.Z
Company Name: Hangzhou AGS MedTech Co., Ltd.

Primary DI Number: 06959664902981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 542984702 *Terms of Use

Device Description: The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
61207	Gastrointestinal endoscopic clip, short-term	A sterile clip intended to be placed short-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. This is a single-use device.	Active	false

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 [?]
K172727	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: Opening Span

Device Record Status

Public Device Record Key: 083761bf-a7b3-498c-87cd-78d597cf7edb
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 28, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
66959664902983	10	56959664902986	In Commercial Distribution	Carton
56959664902986	5	06959664902981	In Commercial Distribution	Box
26959664902985	5	16959664902988	In Commercial Distribution	Carton
16959664902988	10	06959664902981	In Commercial Distribution	Box