AccessGUDID - DEVICE: GEM COUPLER Double Ended Vessel Measuring Gauge (00844735002843)

GUDID

Device Identifier (DI) Information

Brand Name: GEM COUPLER Double Ended Vessel Measuring Gauge
Version or Model: GEM2749
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 519304002010
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735002843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

Device Description: A reusable instrument used to estimate the outside diameter of a blood vessel (1mm - 4mm).

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?
61240	Vascular anastomosis coupling sizer	A non-sterile, hand-held manual surgical instrument designed for use during vascular (including microvascular) anastomosis surgical procedures to estimate the outer diameter of a blood vessel for selection of the appropriate size vascular anastomosis coupler. It is made of metal. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a081ddd9-1ad6-4df1-bd18-def01ce1e7a6
Public Version Date: July 07, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016