FDA.reportPublic FDA data

POINTED AWL

Primary DI
00887868010798
Brand
POINTED AWL
Company
Biomet Orthopedics, LLC
Model
1124-00-000
Catalog number
112400000
Published
2017-04-07
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
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868010798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868010798008878680107988878680107980887868010798

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

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
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
00880304434370Vanguard® Knee System1842811842812015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536161775neon3Ulrich GmbH & Co. KGHWJ2026-05-26
00840311262854CONTACT ALPXtant Medical Holdings, Inc.HWJ2026-03-20
06974940306772endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306857endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306864endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306918endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
00199150066889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-03-02
00190376709246AMP IIALPHATEC SPINE, INC.HWJ2026-02-18
00860015151322EnFix Instrument Kit - TACTETROUS, INC.HWJ2026-02-11
10886982361288NASynthes GmbHHWJ2026-02-11
00860014213427Awl - Non-CuttingTETROUS, INC.HWJ2026-02-10
00860014213434Cutting Awl - 5.5mmTETROUS, INC.HWJ2026-02-10
00860014213441Cutting Awl - 4.5mmTETROUS, INC.HWJ2026-02-10
00888480489818Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489825Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489832Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597001Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597018Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610847Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610861Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610878Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00190376680422ProximityALPHATEC SPINE, INC.HWJ2025-12-19
10889981162252Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
10889981162269Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
03662663242929Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663242950Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243018Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243117Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243209Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243216Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18