FDA.reportPublic FDA data

SMARTO, SMARTO OS

Primary DI
08806390843140
Brand
SMARTO, SMARTO OS
Company
Jeil Medical Corporation
Model
111-ED-050
Published
2018-09-07
Public version status
Update
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
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806390843140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806390843140088063908431408806390843140

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use 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
00840536800244Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
00840536800251Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
07901125600706Minidriver SolarisGM DOS REIS INDUSTRIA E COMERCIO LTDAKIJ2026-02-20
07649988202209FiberLocker PowerUnit - Transfer ShieldZuriMED Technologies AGKIJ2026-02-02
07649988202278FiberLocker PowerUnit - HandpieceZuriMED Technologies AGKIJ2026-02-02
07649988202285FiberLocker PowerUnit - Motor PackZuriMED Technologies AGKIJ2026-02-02
07649988202292FiberLocker PowerUnit - Charging StationZuriMED Technologies AGKIJ2026-02-02
08800038060319EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060326EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060333EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060340EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
00850056900102Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900119Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900126Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900133Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900140Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900157Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900164Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
08800068959348LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959355LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959645LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800017270258BENCOX Surgical InstrumentsCorentec Co., LtdKIJ2025-09-24
08809260475052TD-AUTOSaeshin Precision Co., Ltd.KIJ2025-07-22
008401944934513P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937723P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937893P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944938883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863123P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863293P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321866883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19