FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919581048
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5013853U0
Device description
127.3 VARIO WRCH LG GREEN 1P
Published
2023-03-17
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
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
00887919581048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919581048008879195810488879195810480887919581048

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. 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
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057639712318G-Special SetMC BIO SRLEBL2026-07-28
08057639712325G-Special Set IIMC BIO SRLEBL2026-07-28
08057639712332TACK G-Special-FY SETMC BIO SRLEBL2026-07-28
08057639712349TACK DriverMC BIO SRLEBL2026-07-28
08057639712653Tip WrenchMC BIO SRLEBL2026-07-28
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