AccessGUDID - DEVICE: ISO Adapter For Multi wrench (05712821006462)

GUDID

Device Identifier (DI) Information

Brand Name: ISO Adapter For Multi wrench
Version or Model: C10086
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Elos Medtech Pinol A/S

Primary DI Number: 05712821006462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306155953 *Terms of Use

Device Description: The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.

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?
61946	Surgical torque wrench adaptor	A component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.	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: d5a2aef5-6f08-4d9f-b8a8-c3196370ce6b
Public Version Date: August 31, 2022
Public Version Number: 2
DI Record Publish Date: July 15, 2020