FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08806390849647
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-151
Published
2021-11-23
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

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806390849647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806390849647088063908496478806390849647

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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