AccessGUDID - DEVICE: Drill Extender (05712821001078)

GUDID

Device Identifier (DI) Information

Brand Name: Drill Extender
Version or Model: c7650
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Elos Medtech Pinol A/S

Primary DI Number: 05712821001078
Issuing Agency: GS1
Commercial Distribution End Date: November 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 306155953 *Terms of Use

Device Description: The Elos Drill Extender is for extending tools with ISO 1797 connections. The device is made of stainless steel. The Elos Drill Extender design, finish and quality makes the tool well suited for extending a drill or dental tool and to placement and adjustment of implants, abutments and prosthetic screws. The Elos Drill Extender is easy to prepare for cleaning, disinfection and sterilization.

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: 3e9d74e8-602e-46a6-943e-30e31f836c49
Public Version Date: December 04, 2024
Public Version Number: 3
DI Record Publish Date: March 11, 2020