FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919466994
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5005171U0
Device description
EPM21 EP MANDREL RA LATCH 5P
Published
2022-12-07
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
EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919466994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919466994008879194669948879194669940887919466994

GMDN Terms#

Term, Definition table
TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. 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
00810060227046Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2026-02-10
00810060225967Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225974Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225981Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225998Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226001Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226018Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226025Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226032Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
08800075620965OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
08800075620972OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
00810060225721Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2023-11-09
05060489370006StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370013StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370037StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370044StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370068StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370075StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
00560489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370181StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370174StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370051StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370204Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370198Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
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D248380220Markley Threaded Wire .022HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802500Markley Threaded Wire .025HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802702Markley Threaded Wire .027HAGER WORLDWIDE, INC.EBL2023-04-10
D248380300Markley Threaded Wire .030HAGER WORLDWIDE, INC.EBL2023-04-10