FDA.report

Medicon

Primary DI
04046826157272
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
78.00.03
Catalog number
78.00.03
Device description
lead hand w notches f children
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ILHSPLINT, HAND, AND COMPONENTS

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826157272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826157272040468261572724046826157272

GMDN Terms

TermDefinition
Hand traction plateAn 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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