AccessGUDID - DEVICE: INVASIVE ACCESSORIES AND INSTRUMENTS (D821680FA17)

GUDID

Device Identifier (DI) Information

Brand Name: INVASIVE ACCESSORIES AND INSTRUMENTS
Version or Model: CLAW REAMER BUR 1 u.
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 680FA17
Company Name: RHEIN 83 SRL

Primary DI Number: D821680FA17
Issuing Agency: HIBCC
Commercial Distribution End Date: January 27, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 439240722 *Terms of Use

Device Description: REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the inside of a dental implant.

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?
64627	Dental implant holding endpiece, reusable	A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft with an opening at its distal end designed to be mounted onto the distal end of a manual screwdriver or power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZA	Drill, Dental, Intraoral

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: 912f4bee-e29a-4c1b-9b50-99e53d7dea61
Public Version Date: June 19, 2024
Public Version Number: 3
DI Record Publish Date: January 05, 2021