FDA.report

Medicon

Primary DI
04046826180737
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
350.01.30
Catalog number
350.01.30
Device description
Fox perio pocket probe gauge
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
EIXPROBE, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826180737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826180737040468261807374046826180737

GMDN Terms

TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. 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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