FDA.reportPublic FDA data

ULTRA DRIVE III SET

Primary DI
00880304514034
Brand
ULTRA DRIVE III SET
Company
Biomet Orthopedics, LLC
Model
423955
Catalog number
423955
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXEDEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031280000ULTRA-DRIVE 3Biomet, Inc.2003-09-22JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304514034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304514034008803045140348803045140340880304514034

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816022023657DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023664DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023671DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023688DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023695DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023701DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023718DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.JXE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00887868560880Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560897Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560903Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560910Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560927Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560941Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560958Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00851221006056DPNCheck 2.0NeuroMetrix, Inc.JXE2022-12-20