FDA.reportPublic FDA data

BMT Medizintechnik GmbH

Primary DI
04251725214913
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
OM-75
Catalog number
OM-75
Device description
MOUTH GAG ORINGER, FIG.1
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
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251725214913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251725214913042517252149134251725214913

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
00810158217669PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
B382SD571002EM0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
B382SD572425E0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
00810158217263PRINCETONPrinceton Medical Group, Inc.GAF2025-09-25
04250676741431SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741448SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741455SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
B382SD915095450Surgical DirectSurgical Direct, Inc.GAF2025-08-11
00840343725792GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725808GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725815GEN2SURGIX MEDICAL LLCGAF2025-06-16
10649111448614Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
50649111448612Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
B382SD915039100Surgical DirectSurgical Direct, Inc.GAF2025-05-19