AccessGUDID - DEVICE: Acrobat V Stabilizer (00607567700536)

GUDID

Device Identifier (DI) Information

Brand Name: Acrobat V Stabilizer
Version or Model: OM-9100S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OM-9100S
Company Name: MAQUET CARDIOVASCULAR LLC

Primary DI Number: 00607567700536
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022348156 *Terms of Use

Device Description: Acrobat V Vacuum Off-Pump 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?
62493	Coronary artery exposure retractor	A sterile, tensionable, surgical instrument designed to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self-retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. It is made of stainless steel and is in the form of a clip with leg/prong extensions that uses mechanical spring tension to maintain exposed tissues. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWS	Stabilizer,Heart

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: ae57c1a3-d372-4c73-b6f8-1ea212015f58
Public Version Date: April 09, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016