AccessGUDID - DEVICE: Perclose™ ProStyle™ (08717648235184)

GUDID

Device Identifier (DI) Information

Brand Name: Perclose™ ProStyle™
Version or Model: 12773-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12773-03
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648235184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: Perclose™ ProStyle™ Suture-Mediated Closure and Repair 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":	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?
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. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0992436f-54c2-4ca5-a46b-d8e95e99b620
Public Version Date: August 01, 2023
Public Version Number: 2
DI Record Publish Date: April 01, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
28717648235188	10	08717648235184		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)227-9902
Email: av.customercare@av.abbott.com

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