AccessGUDID - DEVICE: Gen2 (00840343719074)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2DB7012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2DB7012
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343719074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use

Device Description: SMARTLINE micro scissors sh./sh., 190 mm working length 70 mm, curved, bayonet black coated, golden spring

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?
13496	Neurosurgical scissors	A hand-held manual surgical instrument designed to cut tissue (e.g., dura mater, neural soft-tissue) during neurosurgery. It comprises two hinged blades of micro design that cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs. This is a reusable device.	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
Device Size Text, specify: Direction Curved
Length: 190 Millimeter

Device Record Status

Public Device Record Key: 53c755f2-7289-43f9-bf1b-ee8425d06a63
Public Version Date: November 21, 2023
Public Version Number: 1
DI Record Publish Date: November 13, 2023