FDA.report

Medicon

Primary DI
04046826315825
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
331.10.04
Catalog number
331.10.04
Device description
mouth mirror plane fig 4 p/12
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
EAXMIRROR, MOUTH

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826178994PrimaryGS10
04046826315825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826178994040468261789944046826178994
04046826315825040468263158254046826315825

GMDN Terms

TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled 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
12
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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