AccessGUDID - DEVICE: Anastoclip GC Closure System (00840663102457)

GUDID

Device Identifier (DI) Information

Brand Name: Anastoclip GC Closure System
Version or Model: 4007-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4007-06
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663102457
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: Anastoclip GC Closure System, Medium (M)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
36126	Surgical clip applier, single-use	A hand-held manual surgical instrument designed to apply small atraumatic clips for the ligation of blood vessels, or similar tubular anatomy, mainly to stop and/or prevent bleeding (i.e., haemostasis) during an open-surgery procedure. The device is typically a metallic, forceps-like instrument with flat, curved ends to hold and deliver the clips; it may be preloaded with clips and include a mechanism for single or multiple insertions of clips. This is a single-use device that is discarded after a single surgical procedure.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FZP	Clip, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091987	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
No Device Sizes

Device Record Status

Public Device Record Key: 02f2d8e8-7ac6-4906-b6b6-3db8adb0b0f7
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: June 30, 2015