FDA.reportPublic FDA data

ULTRA-DRIVE TOOL

Primary DI
00880304004009
Brand
ULTRA-DRIVE TOOL
Company
Biomet Orthopedics, LLC
Model
423872
Catalog number
423872
Device description
9.5 MM 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
00880304004009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304004009008803040040098803040040090880304004009

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
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

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Primary DI, Brand, Company table
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00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
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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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