FDA.report

BMT Medizintechnik GmbH

Primary DI
04251725214432
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
O-3
Catalog number
O-3
Device description
AMALGAM PLUGGER, #3
Published
2020-05-05
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
04251725214432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04251725214432042517252144324251725214432

GMDN Terms

TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497461966750pmarcis@bmtsurgical.com

Regulatory Flags

DUNS number
342582423
Device count
1
DM exempt
false
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
true
Sterilization required before use
true

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