AccessGUDID - DEVICE: STERNAL WIRE TWISTER NEEDLE HOLDER (00192896082656)

GUDID

Device Identifier (DI) Information

Brand Name: STERNAL WIRE TWISTER NEEDLE HOLDER
Version or Model: 1103-154S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1103-154S
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896082656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: STERNAL WIRE TWISTER NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED BROAD TIP

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?
32874	Wire holding/twisting pliers	A heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. 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 [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 x 20 Millimeter Tip
Length: 5.125 Inch

Device Record Status

Public Device Record Key: 859584d0-28d3-4892-8b84-9b3584918ac0
Public Version Date: September 18, 2019
Public Version Number: 5
DI Record Publish Date: September 21, 2018