FDA.reportPublic FDA data

BMT Medizintechnik GmbH

Primary DI
04251725214999
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
OM-88
Catalog number
OM-88
Device description
SPATULA MALLEABLE, 16X14 MM
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
04251725214999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251725214999042517252149994251725214999

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. 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
00850088713770PRINCETONPrinceton Medical Group, Inc.GAF2026-09-22
04054462902675evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902682evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902750evonosevonos GmbH & Co. KGGAF2026-08-21
04054462917495evonosevonos GmbH & Co. KGGAF2026-08-19
04054462901548evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902699evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902705evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902712evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902729evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902736evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902743evonosevonos GmbH & Co. KGGAF2026-08-18
B382SD571001EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571002EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571004EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
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