FDA.report

BMT Medizintechnik GmbH

Primary DI
04251725212469
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
HE-1
Catalog number
HE-1
Device description
ROOT ELEVATOR HEIDBRINK, STRAIGHT
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
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251725212469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04251725212469042517252124694251725212469

GMDN Terms

TermDefinition
Dental root elevatorA hand-held manual dental instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. 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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