FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08809282815171
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
112-097-1
Published
2018-11-28
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809282815171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809282815171088092828151718809282815171

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
08800089428151Leforte Neuro System Bone PlateNS-3MD-060-06R2026-11-04
08806390889100Leforte Neuro System Bone PlateNS-3MD-200-06R2026-11-04
08806390889087Leforte Neuro System Bone PlateNS-3MD-150-06R2026-11-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810240701137G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701144G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701151G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
07630055307743ROSA® Hip CT Instrument Tray - ShortIncipio Devices SAFSM2026-11-05
07630055307750ROSA® Hip CT Instrument Tray - TallIncipio Devices SAFSM2026-11-05
10889950159429Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-11-05
00889024713505G7® TM Acetabular SystemZimmer, Inc.FSM2026-11-03
05055662976694Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
05055662976717Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
08800322759509GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704070GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704087Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
08800424704094Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
B382SD9233161140Surgical DirectSurgical Direct, Inc.FSM2026-11-03
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02