FDA.reportPublic FDA data

ULTRA-DRIVE TOOL

Primary DI
00880304000452
Brand
ULTRA-DRIVE TOOL
Company
Biomet Orthopedics, LLC
Model
423871
Catalog number
423871
Device description
7MM DISK DRILL
Published
2016-10-03
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

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
K900003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900003000SYSTEM TEN MODEL 100 SURGICAL SYSTEMAdvanced Osseous Technologies1990-03-16JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304000452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304000452008803040004528803040004520880304000452

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical system handpiece tipA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., 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 is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-348-9500customerservice@biomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

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Primary DI, Brand, Company table
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00816022023718DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
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00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
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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
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