AccessGUDID - DEVICE: N/A (00889024368804)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 00-0923-002-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-0923-002-00
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024368804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: ZIMMER SPREADER BLOCK WIDTH: 2 INCHES

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?
46525	Bed traction frame	An adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).	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
Width: 2 Inch

Device Record Status

Public Device Record Key: 1287e270-d98c-40bd-a53f-095955b8777a
Public Version Date: December 22, 2020
Public Version Number: 1
DI Record Publish Date: December 14, 2020