AccessGUDID - DEVICE: INVASIVE ACCESSORIES AND INSTRUMENTS (08059224072418)

GUDID

Device Identifier (DI) Information

Brand Name: INVASIVE ACCESSORIES AND INSTRUMENTS
Version or Model: ESTRATTORE x IMP. ReplaceSelect ø 5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 780RPS5
Company Name: RHEIN 83 SRL

Primary DI Number: 08059224072418
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439240722 *Terms of Use

Device Description: Burs used to remove broken screws from the internal thread of the 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:	No
Prescription Use (Rx):	No
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: d072b83b-88ea-44c0-9833-60b60d1a0d26
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: July 08, 2022