AccessGUDID - DEVICE: GEO Bone Screw System (B471210201000)

GUDID

Device Identifier (DI) Information

Brand Name: GEO Bone Screw System
Version or Model: 21020100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC

Primary DI Number: B471210201000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080068420 *Terms of Use

Device Description: Drill Bit 2.0mmx100mm AO Cannulated

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?
61235	Cannulated surgical drill bit, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTW	BIT, DRILL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161904	000

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
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Millimeter
Outer Diameter: 2.0 Millimeter

Device Record Status

Public Device Record Key: 00c8b8e0-e528-4a11-a17b-0a4e0a9c4cc1
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: October 10, 2018