AccessGUDID - DEVICE: APOLLO Ankle Fracture Plating System (18435711004938)

GUDID

Device Identifier (DI) Information

Brand Name: APOLLO Ankle Fracture Plating System
Version or Model: F4-3012-000S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F4-3012-000S
Company Name: Glw, Inc.

Primary DI Number: 18435711004938
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081102081 *Terms of Use

Device Description: Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø4.5 / for Screw 4.3

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):	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?
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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: 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: 77e93002-8f96-4d45-b214-4eea70b84d18
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025