FDA.report

Medicon

Primary DI
04046826160470
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
79.68.70
Catalog number
79.68.70
Device description
rachiotome 22cm
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
EMFKNIFE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826160470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826160470040468261604704046826160470

GMDN Terms

TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). 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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