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
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

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