AccessGUDID - DEVICE: Key Surgical Hemostasis Clips (00849771039204)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Hemostasis Clips
Version or Model: EN10400A.16
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EN10400A16
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771039204
Issuing Agency: GS1
Commercial Distribution End Date: November 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Hemostasis Clip, Rotatable, Single-Use, Coated, 16mm (Opening) W

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":	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
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Opening span 16mm

Device Record Status

Public Device Record Key: eed7c0aa-a249-4d4d-89b0-1e806b338416
Public Version Date: November 13, 2023
Public Version Number: 4
DI Record Publish Date: February 03, 2020