AccessGUDID - DEVICE: Zimmer® Universal Power System (14053613171820)

GUDID

Device Identifier (DI) Information

Brand Name: Zimmer® Universal Power System
Version or Model: 89-8508-041-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 89-8508-041-25
Company Name: Gebr. Brasseler GmbH & Co. KG

Primary DI Number: 14053613171820
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317409001 *Terms of Use

Device Description: Radiolucent Drill 2.5 x 148 mm, Tri-Fluted, ZMH Shank

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?
45553	Orthopaedic bur, single-use	A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFG	Bit, Surgical

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: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: ba52e051-13d4-4312-8b9d-3eabfd4be6bb
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022