AccessGUDID - DEVICE: APEX 3D Total Ankle Replacement System (00889795114037)

GUDID

Device Identifier (DI) Information

Brand Name: APEX 3D Total Ankle Replacement System
Version or Model: P10-851-TPR4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P10-851-TPR4
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795114037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 4

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
64337	Bone-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTO	REAMER

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: 4239279e-8f7c-46a8-ba7c-5bbd7d560583
Public Version Date: April 22, 2025
Public Version Number: 2
DI Record Publish Date: September 14, 2022