FDA.report

Medicon

Primary DI
04046826045074
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
40.66.05
Catalog number
40.66.05
Device description
Engel plaster saw 15cm
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
LGGINSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826045074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826045074040468260450744046826045074

GMDN Terms

TermDefinition
Cast/plaster knifeA flat-bladed, hand-held, instrument with a short, strong cutting blade with a sharp edge that is used to cut or trim the plaster of a cast. It is typically a one-piece device made of high-grade stainless steel. 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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