AccessGUDID - DEVICE: N/A (00885825011895)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: N/A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 310.21
Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.

Primary DI Number: 00885825011895
Issuing Agency: GS1
Commercial Distribution End Date: December 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 020198912 *Terms of Use

Device Description: Drill Bit, QC

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?
61802	Bone tap, reprocessed	A sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end, and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached, whereby it will typically be manually rotated. This is a previously used single-use device that has been processed for an additional single-use patient application.	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
Device Size Text, specify: Diameter: 2.0 Millimeter
Length: 125.0 Millimeter

Device Record Status

Public Device Record Key: 538cf29b-80f7-4059-aa94-52196d7f0ab1
Public Version Date: December 19, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016