AccessGUDID - DEVICE: Gen2 (00840343701246)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2G21360
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2G21360
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343701246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2G213600

Device Description: T-C STERNAL NEEDLE HOLDER/WIRE TWISTER 8''

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?
32881	Wire twister	A surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHQ	Holder, Needle, Gastroenterologic

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: 8 Inch

Device Record Status

Public Device Record Key: 444f203c-0eef-4f67-a44a-14278ab7600e
Public Version Date: October 27, 2022
Public Version Number: 1
DI Record Publish Date: October 19, 2022