AccessGUDID - DEVICE: BioHorizons (00847236006969)

GUDID

Device Identifier (DI) Information

Brand Name: BioHorizons
Version or Model: 300-206
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOHORIZONS IMPLANT SYSTEMS, INC

Primary DI Number: 00847236006969
Issuing Agency: GS1
Commercial Distribution End Date: July 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 967279910 *Terms of Use

Device Description: 4mm Square Driver Extender

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):	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?
45320	Dental drill bit extension	A device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: 5045949b-b319-4ed0-adf0-de56c75b2fe2
Public Version Date: July 14, 2023
Public Version Number: 3
DI Record Publish Date: April 11, 2016