AccessGUDID - DEVICE: NA (10705034769127)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 321.744
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 321744
Company Name: SYNTHES (U.S.A.) LP

Primary DI Number: 10705034769127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832637081 *Terms of Use

Device Description: PRETENSIONER

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Internal spinal fixation system cable tensioner	A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Internal spinal fixation system cable tensioner

A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HXW	BENDER

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
No Device Sizes

Device Record Status

Public Device Record Key: 57f88040-f498-4007-a67a-3a38872c8ebe
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 31, 2016