AccessGUDID - DEVICE: PERCLOSE (08717648013065)

GUDID

Device Identifier (DI) Information

Brand Name: PERCLOSE
Version or Model: 12337-04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12337-04
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648013065
Issuing Agency: GS1
Commercial Distribution End Date: February 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 095979332 *Terms of Use

Device Description: PERCLOSE A-T 6F Suture-Medicated Closure System

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":	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?
52747	Femoral vessel suture implantation set	A collection of hand-operated instruments designed for the percutaneous delivery of sutures to close a femoral artery or vein puncture site following a catheterization procedure; it is intended to reduce the time to haemostasis and ambulation for the patient. The collection typically consists of a sheath containing suture needles with sutures, needle guide, and a marker to control the placement of needles around the puncture site; and a suture knot pusher. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MGB	DEVICE, HEMOSTASIS, VASCULAR

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
Special Storage Condition, Specify: Keep dry. Store in a cool place (room temperature).

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55d69b03-49af-4f34-86aa-260a11ba7c28
Public Version Date: February 19, 2021
Public Version Number: 4
DI Record Publish Date: November 14, 2014