FDA.report

LOSPA IS Spinal System

Primary DI
08800017288376
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
SI.C40.0005
Device description
DLIF Illumination cable
Published
2022-10-21
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

Contact Domains

Product Codes

CodeName
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800017288376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800017288376088000172883768800017288376

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82415857114sungwon.yang@corentec.com

Regulatory Flags

DUNS number
688739895
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

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08809945895083EXULT Surgical InstrumentKZ.024.Z0242026-02-20
08809945895090EXULT Surgical InstrumentKZ.024.Z0252026-02-20
08809945895106EXULT Surgical InstrumentKZ.024.Z0262026-02-20
08809945895113EXULT Surgical InstrumentKZ.024.Z0272026-02-20
08809945895120EXULT Surgical InstrumentKZ.024.Z0282026-02-20
08800017271101Bencox Hip SystemHA.02J.00012018-11-21
08800017278230Bencox Hip SystemHZ.012.00012018-11-22
08800017285405Bencox Hip SystemHA.0B2.00012018-11-22
08800017299358BENCOX Surgical Instruments01.51.771.062026-01-12
08806373874215Bencox Hip SystemHA.013.00042018-11-21
08806373887734BENCOX Surgical Instruments01.51.7712026-01-12
08806373887826BENCOX Surgical Instruments01.51.8882026-01-12
08806373887833BENCOX Surgical Instruments01.51.888.012026-01-12

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00887919971795Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00763000714635MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
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10885862090560NAExactech, Inc.HSZ2022-09-19
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10885862090225NAExactech, Inc.HSZ2022-07-28
10885862090232NAExactech, Inc.HSZ2022-07-28
10885862090256NAExactech, Inc.HSZ2022-07-28
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10885862090362NAExactech, Inc.HSZ2022-07-28
10885862090379NAExactech, Inc.HSZ2022-07-28
10885862090416NAExactech, Inc.HSZ2022-07-28
10885862090423NAExactech, Inc.HSZ2022-07-28
10885862090430NAExactech, Inc.HSZ2022-07-28
10885862090485NAExactech, Inc.HSZ2022-07-28
10885862090492NAExactech, Inc.HSZ2022-07-28
10885862090508NAExactech, Inc.HSZ2022-07-28
10885862090522NAExactech, Inc.HSZ2022-07-28
10885862090539NAExactech, Inc.HSZ2022-07-28
10885862090546NAExactech, Inc.HSZ2022-07-28
00763000513443MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
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