AccessGUDID - DEVICE: NEW ORLEANS WIRE TWISTER (00192896062979)

GUDID

Device Identifier (DI) Information

Brand Name: NEW ORLEANS WIRE TWISTER
Version or Model: 2300-602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2300-602
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896062979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: NEW ORLEANS WIRE TWISTER NEEDLE HOLDER BLUNT TUNGSTEN CARBIDE SERRATED JAW

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
HXS	Twister, Wire

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 [?]
Dry Heat Sterilization
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 Record Status

Public Device Record Key: 77385697-0942-4094-9dd8-d00190f7a347
Public Version Date: April 02, 2025
Public Version Number: 4
DI Record Publish Date: September 18, 2018