AccessGUDID - DEVICE: AXIOM® (03663394482820)

GUDID

Device Identifier (DI) Information

Brand Name: AXIOM®
Version or Model: OPGU180
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ETABLISSEMENTS ANTHOGYR

Primary DI Number: 03663394482820
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 275978864 *Terms of Use

Device Description: AXIOM BL Ø1.80 SERVICE GUIDE

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?
62358	Screw extractor, reusable	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.	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
Outer Diameter: 1.8 Millimeter

Device Record Status

Public Device Record Key: e9abb2d7-e6cd-4e8f-ac48-3039f8523bfc
Public Version Date: December 28, 2023
Public Version Number: 1
DI Record Publish Date: December 20, 2023