AccessGUDID - DEVICE: 5.0mm Drill, Cann, Hudson-Mod, 300mm (00816950027925)

GUDID

Device Identifier (DI) Information

Brand Name: 5.0mm Drill, Cann, Hudson-Mod, 300mm
Version or Model: 2004-0008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2004-0008
Company Name: Osteocentric Technologies, Inc.

Primary DI Number: 00816950027925
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089645059 *Terms of Use

Device Description: 5.0mm Drill, Cann, Hudson-Mod, 300mm

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?
63681	Cannulated surgical drill bit, single-use, non-sterile	A non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HTW	Bit, Drill

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170021	000

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
Length: 300 Millimeter

Device Record Status

Public Device Record Key: 2b09a0e3-e34b-47f1-8201-2acf5780b011
Public Version Date: August 16, 2023
Public Version Number: 3
DI Record Publish Date: June 17, 2020