FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919879213
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5028388M0
Device description
BR357-399 3.2MM X 400MM
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919879213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919879213008879198792138879198792130887919879213

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, sterileA small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use 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
Expiration date on label
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
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525324Onyx 6.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525348Onyx 4.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525355Onyx 5.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525362Onyx 6.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525379Onyx 7.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
00810055525393Onyx Straight ProbeSi-Bone Inc.LXH2026-09-29
00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29
00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
00810055525461Onyx Counter TorqueSi-Bone Inc.LXH2026-09-29
00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29