FDA.report

Medicon

Primary DI
04046826000592
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
01.51.05
Catalog number
01.51.05
Device description
Dieffenbach scalpel 16cm fig 5
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
GDXSCALPEL, ONE-PIECE

Product Code Classifications

CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826000592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826000592040468260005924046826000592

GMDN Terms

TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. 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
true
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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36945630139063index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139070index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
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