AccessGUDID - DEVICE: Padlock Clip Pro-Select (00816765013809)

GUDID

Device Identifier (DI) Information

Brand Name: Padlock Clip Pro-Select
Version or Model: C913131
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C913131
Company Name: US Endoscopy

Primary DI Number: 00816765013809
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00864345000015

Device Description: The Padlock Clip Pro-select is used in flexible endoscopy for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

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 [?]
K120814	000
K180689	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
Length: 162 Centimeter

Device Record Status

Public Device Record Key: a04e72a3-b859-4ff4-ac1d-a5a47b796432
Public Version Date: April 07, 2021
Public Version Number: 9
DI Record Publish Date: November 03, 2017