FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919761174
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025500U0
Device description
STEEL MIXING BOWL 1P
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00887919761174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919761174008879197611748879197611740887919761174

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing surface, chairside, reusableA slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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