AccessGUDID - DEVICE: Universal Neuro 2, Universal Neuro 3 (04546540394156)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Neuro 2, Universal Neuro 3
Version or Model: 60-12306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-12306
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540394156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: DRILL, WL 6MM, TPS SHAFT

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?
43390	Fluted surgical drill bit, single-use	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

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: 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
Length: 6.0 Millimeter
Length: 87.0 Millimeter
Device Size Text, specify: Diameter: 1.2 Millimeter

Device Record Status

Public Device Record Key: bc571328-9e75-4a25-b05b-35c826e6f2ba
Public Version Date: April 12, 2021
Public Version Number: 4
DI Record Publish Date: August 24, 2016