FDA.reportPublic FDA data

3.2MM DRILL BIT 280MM

Primary DI
00887868081699
Brand
3.2MM DRILL BIT 280MM
Company
Biomet Orthopedics, LLC
Model
03037
Catalog number
03037
Published
2020-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868081699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868081699008878680816998878680816990887868081699

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy drill bitA shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024709188DISTAL GRADUATED DRILL SHORT2112-01-4062112014062026-07-24
00889024709195DRILL MEASURING SLEEVE2112-01-4102112014102026-07-24
00880304533424DVR® CrosslockWIDE PLATE RIGHT (HEAD WIDTH x OVERALL LENGTH)1318130501318130502015-10-24
00889024707726SolidLok®2810-01-0212810010212026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089526579AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528047AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528344AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528351AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089529976AMPLITUDEAMPLITUDE SASHTW2026-07-29
03700569674359Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569674366Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569674700Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569679194Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569680220Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569680237Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
00810135961264ToejackNVision Biomedical Technologies, Inc.HTW2026-07-24
00889024709188DISTAL GRADUATED DRILL SHORTBiomet Orthopedics, LLCHTW2026-07-24
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.HTW2026-07-22