FDA.report

Surgical Instrument

Primary DI
08800089448647
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-402
Published
2024-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWJAwl

Product Code Classifications

CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800089448647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800089448647088000894486478800089448647

GMDN Terms

TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is 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, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811603
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800089480128Summa Orthopaedics Femur Nail SystemSO-SPFL-A0702026-02-23
08800089480135Summa Orthopaedics Femur Nail SystemSO-SPFL-A0752026-02-23
08800089480142Summa Orthopaedics Femur Nail SystemSO-SPFL-A0802026-02-23
08800089480159Summa Orthopaedics Femur Nail SystemSO-SPFL-A0852026-02-23
08800089480166Summa Orthopaedics Femur Nail SystemSO-SPFL-A0902026-02-23
08800089480173Summa Orthopaedics Femur Nail SystemSO-SPFL-A0952026-02-23
08800089480180Summa Orthopaedics Femur Nail SystemSO-SPFL-A1002026-02-23
08800089480197Summa Orthopaedics Femur Nail SystemSO-SPFL-A1052026-02-23
08800089480203Summa Orthopaedics Femur Nail SystemSO-SPFL-A1102026-02-23
08800089480210Summa Orthopaedics Femur Nail SystemSO-SPFL-A1152026-02-23
08800089480227Summa Orthopaedics Femur Nail SystemSO-SPFL-A1202026-02-23
08800089480234Summa Orthopaedics Femur Nail SystemSO-SPFL-A1252026-02-23
08800089480241Summa Orthopaedics Femur Nail SystemSO-SPFL-A1302026-02-23
08800089480258Summa Orthopaedics Femur Nail SystemSO-SPFL-T0852026-02-23
08800089480265Summa Orthopaedics Femur Nail SystemSO-SPFL-T0902026-02-23
08800089480272Summa Orthopaedics Femur Nail SystemSO-SPFL-T0952026-02-23
08800089480289Summa Orthopaedics Femur Nail SystemSO-SPFL-T1002026-02-23
08800089480296Summa Orthopaedics Femur Nail SystemSO-SPFL-T1052026-02-23
08800089480302Summa Orthopaedics Femur Nail SystemSO-SPFL-T1102026-02-23
08800089480319Summa Orthopaedics Femur Nail SystemSO-SPFL-T1152026-02-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
03662663244725Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWJ2025-12-18