FDA.report

Surgical Instrument

Primary DI
08800089422425
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
112-159-2
Published
2021-11-30
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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800089422425PrimaryGS10

GMDN Terms

TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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

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