AccessGUDID - DEVICE: SURGICAL INSTRUMENT (07899995210746)

GUDID

Device Identifier (DI) Information

Brand Name: SURGICAL INSTRUMENT
Version or Model: MI 3415
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MI 3415
Company Name: Sin Sistema de Implante Nacional S/A

Primary DI Number: 07899995210746
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 904569092 *Terms of Use

Device Description: IMPLANT FIXER MICRO MINI LONG

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
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201688	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 5de8887f-25ad-4d16-b6d0-c19cfb7a50de
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: March 30, 2021