AccessGUDID - DEVICE: Zimmer® Cannulated Screw System (00846468071387)

GUDID

Device Identifier (DI) Information

Brand Name: Zimmer® Cannulated Screw System
Version or Model: 00-1147-096-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-1147-096-00
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468071387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: WASHER, 7.0mm X 3.5mm (3.5mm, 4.0mm SCREWS)

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:	Yes
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?
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	WASHER, BOLT NUT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003496	000

Device Exempt from Premarket Submission: No 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: 1e38ae8c-f8ad-4197-9ad3-e49bc7653199
Public Version Date: March 04, 2025
Public Version Number: 4
DI Record Publish Date: September 11, 2018