DEVICE: Medicon (04046826157326)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

Medicon
78.00.20
In Commercial Distribution
78.00.20
Medicon eG. Chirurgiemechaniker-Genossenschaft
04046826157326
GS1

1
315492330 *Terms of Use
hand fixation plate teflon acc Dr Funke
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40633 Hand traction plate
An orthopaedic device designed as a flat plate with converging slots and clamps onto which the patient's hand is placed and held (locked) through the application of the clamps to the fingers so that traction can be applied to the hand and fingers. Also known as a Weinberger hand traction device, it is used during orthopaedic surgical procedures on the hand/wrist when broken bones are being drawn apart, repositioned, and set to the correct position. It is available in various sizes (adult or child) and has a solid plate construction (typically radiotranslucent) which can be securely attached/locked to other components of the table. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ILH SPLINT, HAND, AND COMPONENTS
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f593b1b6-8020-4027-849e-3d96babfe199
October 02, 2020
1
September 24, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+490746220090
sales@medicon.de
CLOSE