FDA.report

Medicon

Primary DI
04046826136383
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
74.47.20
Catalog number
74.47.20
Device description
endolaryngeal probe 24cm
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
KCHHOOK, TRACHEAL

Product Code Classifications

CodeDeviceSpecialtyClass
KCHHook, TrachealEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826136383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826136383040468261363834046826136383

GMDN Terms

TermDefinition
ENT probe, reusableA slender, rod-like, hand-held manual surgical instrument, typically with a blunt bulbous or pointed tip, used for exploring fistulas, cavities or wounds used during ear/nose/throat (ENT) intervention. The distal end of the instrument, before the bulb/point, may be bent at a right angle to the shaft. 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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