AccessGUDID - DEVICE: N/A (00889024368736)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 00-0849-001-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00-0849-001-00
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024368736
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: HEAD HALTER SPREADER BAR 6 INCHES LONG

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?
35359	Traction system spreader bar	A metal bar that has curved-hoop segments for attaching hooks or pins to perform traction with an external traction system. The bar is adjustable and is used to vary the angle at which the system's cord applies traction, via harnesses attached to the head or pelvic area, to affect the cervical or lumbar vertebrae.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HST	Apparatus, Traction, Non-Powered

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 065d60f6-179a-4d01-96d3-a335f3d3b43c
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: December 11, 2020