AccessGUDID - DEVICE: GEM Microvascular Anastomotic COUPLER (00844735002591)

GUDID

Device Identifier (DI) Information

Brand Name: GEM Microvascular Anastomotic COUPLER
Version or Model: GEM2750 I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 511100100010
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735002591
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

Device Description: The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. The GEM Microvascular Anastomotic COUPLER Device is single-use and available in various sizes

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
18137	Vascular anastomosis coupler, basic	An implantable device intended to be used to permanently join vascular structures (blood vessels) through the coupling of two ring-shaped components that are inserted into the ends of the vessels to be attached. It is also used in microvascular surgery. This device is made of a substance or material that cannot be chemically degraded or absorbed via natural body processes (e.g., stainless steel).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MVR	Device,anastomotic,microvascular

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6f56133-fce2-46f3-9131-235e0437c486
Public Version Date: July 20, 2023
Public Version Number: 4
DI Record Publish Date: October 08, 2015