AccessGUDID - DEVICE: Artemis Proximal Femoral Nail System (18400659000120)

GUDID

Device Identifier (DI) Information

Brand Name: Artemis Proximal Femoral Nail System
Version or Model: T5-0170-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T5-0170-000
Company Name: Glw, Inc.

Primary DI Number: 18400659000120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081102081 *Terms of Use

Device Description: ARTEMIS nail PF, Opening Reamer, Zimmer/Hall coupling

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?
65880	Orthopaedic implant reamer	A surgical tool designed to over-drill a cylindrical orthopaedic implant (screw, pin, intrameduallry nail) to facilitate its removal by excising overgrown bone or other tissue. It is in the form of a hollow fluted metal shaft, with saw teeth at the cutting edge, available in a variety of sizes to match the different sizes of implant. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: 7fa03172-7240-443c-8735-125d30722dad
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025