AccessGUDID - DEVICE: AVALIGN (00850011214077)

GUDID

Device Identifier (DI) Information

Brand Name: AVALIGN
Version or Model: PMI-RD-D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMI-RD-D
Company Name: PROGRESSIVE MEDICAL INSTRUMENTATION INC

Primary DI Number: 00850011214077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131054074 *Terms of Use

Device Description: APPROXIMATOR CLAMPS W/O FRAME

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:	No
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?
62471	Coronary artery clamp	A hand-held, manual surgical instrument designed to directly compress a coronary artery during coronary artery graft surgery to create a temporary atraumatic haemostasis (arrest or prevention of bleeding). It may be referred to as a clip or a clamp, is made of plastic, and has a self-retaining design; it is not in the form of a bulldog clamp nor scissors-like forceps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 7649be5b-34d3-450e-8c38-ab6aa2c3de18
Public Version Date: July 22, 2021
Public Version Number: 2
DI Record Publish Date: September 06, 2019