AccessGUDID - DEVICE: Padlock Clip-12 (00864345000008)

GUDID

Device Identifier (DI) Information

Brand Name: Padlock Clip-12
Version or Model: C910001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C910001
Company Name: APONOS MEDICAL CORPORATION

Primary DI Number: 00864345000008
Issuing Agency: GS1
Commercial Distribution End Date: December 14, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 829951404 *Terms of Use

Device Description: Endoscopic Ligation Clip

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?
38144	Wound clip, non-biodegradable	A device designed for the temporary, atraumatic approximation of the edges of a wound during a surgical procedure. It is typically a small, usually metallic, instrument with two blades joined at the mid-portion, or made of a single alpha-shaped part. It is typically applied manually. The device is mainly used to arrest bleeding (i.e., haemostasis); it may be used to facilitate the placing of sutures to close wounds. This is a single-use device.	Obsolete	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 [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: d0742cf7-7bbc-47af-be51-b3da2b242564
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 09, 2016