AccessGUDID - DEVICE: Handpiece Guide Fixation Screw Driver (07290109301082)

GUDID

Device Identifier (DI) Information

Brand Name: Handpiece Guide Fixation Screw Driver
Version or Model: GS0028
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADIN DENTAL IMPLANT SYSTEMS LTD

Primary DI Number: 07290109301082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533289435 *Terms of Use

Device Description: No description.

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?
45574	Dental power tool converter attachment, non-rotary	A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a sagittal, oscillating or reciprocating mechanical motion to achieve a specific function (e.g., sawing) during dental procedures [e.g., maxillofacial surgery]. It is not an endpiece; an appropriate interchangeable endpiece (e.g., saw blade) is intended to be fixed to the working end of this device. This is a reusable device.	Obsolete	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: 460f7ed0-a451-417b-a261-f426facb672a
Public Version Date: December 03, 2020
Public Version Number: 1
DI Record Publish Date: November 25, 2020