FDA.report

BMT Medizintechnik GmbH

Primary DI
04251725214500
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
OBN-4
Catalog number
OBN-4
Device description
GINGIVECTOMY KNIFE ORBAN, DOUBLE, #1/2
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
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251725214500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04251725214500042517252145004251725214500

GMDN Terms

TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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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04251725200114BMT Medizintechnik GmbH442020-05-05
04251725200121BMT Medizintechnik GmbH46-L46-L2020-05-05
04251725200138BMT Medizintechnik GmbH48482020-05-05
04251725200152BMT Medizintechnik GmbH51512020-05-05
04251725200169BMT Medizintechnik GmbH51-A51-A2020-05-05
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04251725200183BMT Medizintechnik GmbH56562020-05-05
04251725200190BMT Medizintechnik GmbH67-A67-A2020-05-05
04251725200206BMT Medizintechnik GmbH772020-05-05
04251725200213BMT Medizintechnik GmbH707-16D1707-16D12020-05-05

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