FDA.reportPublic FDA data

BMT Medizintechnik GmbH

Primary DI
04251725218645
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
FL-184
Catalog number
FL-184
Device description
OSTEOTOME PARTSCH, 7 MM, 17 CM
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251725218645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251725218645042517252186454251725218645

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461966750pmarcis@bmtsurgical.com

Regulatory Flags#

DUNS number
342582423
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251725206727BMT Medizintechnik GmbHDL-60DL-602020-05-05
04251725206895BMT Medizintechnik GmbHDL-CDL-C2020-05-05
04251725206901BMT Medizintechnik GmbHDL-VDL-V2020-05-05
04251725207519BMT Medizintechnik GmbHDP-24DP-242020-05-05
04251725214111BMT Medizintechnik GmbHMRT-6MRT-62020-05-05
04251725214128BMT Medizintechnik GmbHMRT-7MRT-72020-05-05
04251725214135BMT Medizintechnik GmbHMRT-C1MRT-C12020-05-05
04251725214142BMT Medizintechnik GmbHMRT-C3MRT-C32020-05-05
04251725214159BMT Medizintechnik GmbHMRT-C4MRT-C42020-05-05
04251725214166BMT Medizintechnik GmbHMRT-C7MRT-C72020-05-05
04251725216153BMT Medizintechnik GmbHPH-60PH-602020-05-05
04251725224233BMT Medizintechnik GmbHDP-136DP-1362020-05-05
04251725205973BMT Medizintechnik GmbHDB-180DB-1802020-05-05
04251725205980BMT Medizintechnik GmbHDB-181DB-1812020-05-05
04251725205997BMT Medizintechnik GmbHDB-182DB-1822020-05-05
04251725211691BMT Medizintechnik GmbHFO-162FO-1622020-05-05
04251725211707BMT Medizintechnik GmbHFO-163FO-1632020-05-05
04251725211714BMT Medizintechnik GmbHFO-165FO-1652020-05-05
04251725211820BMT Medizintechnik GmbHFO-33FO-332020-05-05
04251725220105BMT Medizintechnik GmbHDB-177DB-1772020-05-05

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