AccessGUDID - DEVICE: Key Surgical Drill Bits (00849771026464)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Drill Bits
Version or Model: KI-86-8445
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771026464
Issuing Agency: GS1
Commercial Distribution End Date: January 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Twist Drill Bit, 5-inch str shank double fluted, 4.5mm diameter, 34mm, round end

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):	No
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?
32390	Fluted surgical drill bit, reusable	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 usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTW	Bit, Drill

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: 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: 356afbf6-ffb0-401e-a9af-f3505856de00
Public Version Date: January 24, 2023
Public Version Number: 4
DI Record Publish Date: December 21, 2020