FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919589440
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5014499U0
Device description
76D-8A RUBBER DAM CLAMP 1P
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EEFCLAMP, RUBBER DAM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919589440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919589440008879195894408879195894400887919589440

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clampA dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. 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
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535030822Brasseler USA5032378U05032378U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075627704OSUNG MNDOSUNG MND Co., Ltd.EEF2025-11-03
00889813063606Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-12-12
00889813063613Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-11-30
00889813063620Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-11-30
00889813063576Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-10-01
00889813063590Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-10-01
08800075603364OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603371OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603388OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603395OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603401OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075621313OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603357OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075603418OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075603425OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075603432OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075621320OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075626424OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08964003163228NivoB. Ali ImpexEEF2024-01-27
08964003163235NivoB. Ali ImpexEEF2024-01-27
08964003163242NivoB. Ali ImpexEEF2024-01-27
08964003163259NivoB. Ali ImpexEEF2024-01-27
08964003163266NivoB. Ali ImpexEEF2024-01-27
08964003163204NivoB. Ali ImpexEEF2024-01-25
08964003163211NivoB. Ali ImpexEEF2024-01-25
10889950088200Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950088217Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950121754Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950121761Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950133986Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03