AccessGUDID - DEVICE: Medicon Epiplating System (04046826123697)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon Epiplating System
Version or Model: 68.80.41
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 68.80.41
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826123697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: covering screw for prosthesis plates

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:	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?
47748	Orthopaedic fixation plate bending insert, reusable	A device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head (for the acceptance of a screwdriver) used solely during the bending of plates that typically have a continuous row of screw holes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZE	Prosthesis, Nose, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241253	000

Device Exempt from Premarket Submission: No 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: 9fe0355e-2704-4cc3-af32-8aee9b4ff78c
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025