AccessGUDID - DEVICE: TPS (04546540980816)

GUDID

Device Identifier (DI) Information

Brand Name: TPS
Version or Model: 5100088000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5100-088-000
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540980816
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Micro Driver

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?
33541	Bone/joint surgical power tool motor, electric	A hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of non-dental surgical procedures such as drilling or sawing of bones and tough tissues. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZJ	DRIVER, WIRE, AND BONE DRILL, MANUAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 5ca6409c-b4b7-46d7-be6b-b7079984dbb6
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2016