FDA.report

Medicon

Primary DI
04046826102852
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
62.15.05
Catalog number
62.15.05
Device description
Zaufal ear probe 16cm
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
KAKPROBE, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826102852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826102852040468261028524046826102852

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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