FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08809282815430
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-067-2
Published
2018-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GAHStylet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809282815430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809282815430088092828154308809282815430

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811603
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089487820Surgical Instrument113-HF-7182026-10-26
08800089483440Surgical InstrumentS111-356-42026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentSO-S111-356-42026-06-10
08800089483433Drill bit111-6062026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentSO-111-6062026-06-10
08800089479450ARIX System Bone Screw35N-SO-L20-TA2026-06-01
08800089479467ARIX System Bone Screw35N-SO-L22-TA2026-06-01
08800089479474ARIX System Bone Screw35N-SO-L24-TA2026-06-01
08800089479481ARIX System Bone Screw35N-SO-L26-TA2026-06-01
08800089479498ARIX System Bone Screw35N-SO-L28-TA2026-06-01
08800089479504ARIX System Bone Screw35N-SO-L30-TA2026-06-01
08800089479511ARIX System Bone Screw35N-SO-L32-TA2026-06-01
08800089479528ARIX System Bone Screw35N-SO-L34-TA2026-06-01
08800089479535ARIX System Bone Screw35N-SO-L36-TA2026-06-01
08800089479542ARIX System Bone Screw35N-SO-L38-TA2026-06-01
08800089479559ARIX System Bone Screw35N-SO-L40-TA2026-06-01
08800089479566ARIX System Bone Screw35N-SO-L42-TA2026-06-01
08800089479573ARIX System Bone Screw35N-SO-L44-TA2026-06-01
08800089479580ARIX System Bone Screw35N-SO-L46-TA2026-06-01
08800089479597ARIX System Bone Screw35N-SO-L48-TA2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663192873Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192897Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192903Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192910Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192927Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
00873263009314Visualase Neuro AccessoriesFHC, INC.GAH2025-12-12
00873263009338Visualase MR Stiffening StyletFHC, INC.GAH2025-12-12
03662663131414Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131506Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131513Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131520Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131537Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
08809204330522LIONHans Biomed Corp.GAH2025-11-26
08809204330539LIONHans Biomed Corp.GAH2025-11-26
08809204330546LIONHans Biomed Corp.GAH2025-11-26
08809204330553LIONHans Biomed Corp.GAH2025-11-26
08809204330560LIONHans Biomed Corp.GAH2025-11-26
08809204330577LIONHans Biomed Corp.GAH2025-11-26
08809204330584LIONHans Biomed Corp.GAH2025-11-26
08809204330591LIONHans Biomed Corp.GAH2025-11-26
08809204330607LIONHans Biomed Corp.GAH2025-11-26
08809204330614LIONHans Biomed Corp.GAH2025-11-26
08809204330621LIONHans Biomed Corp.GAH2025-11-26
08809204330638LIONHans Biomed Corp.GAH2025-11-26
08809204330645LIONHans Biomed Corp.GAH2025-11-26
08809204330652LIONHans Biomed Corp.GAH2025-11-26
08809779585853LIONHans Biomed Corp.GAH2025-11-26
08809779585877LIONHans Biomed Corp.GAH2025-11-26
08809204330515LIONHans Biomed Corp.GAH2025-11-18
00873263009062Visualase Neuro AccessoriesFHC, INC.GAH2025-03-10