AccessGUDID - DEVICE: Gen2 (00840343700096)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2C62297
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2C62297
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343700096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2C622970

Device Description: VASCULAR SCISSOR, ROUND HANDLE, 8MM DIAMETER, STR. 6"

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?
44354	Vascular scissors	A hand-held, manual surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. Often referred to as micro-scissors, it is a metallic device with two small pivoted blades which cut with a shearing action. The blades are often pointed to penetrate the vessel wall, may be straight, curved sideways, or acutely angled, and may include carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRW	Scissors, General, Surgical

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
Length: 6 Inch
Device Size Text, specify: Diameter, 8 mm

Device Record Status

Public Device Record Key: 01301689-028b-4c0d-a3e9-8b587fe9f9e0
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022