FDA.report

Spine Instruments

Primary DI
08800113396067
Brand
Spine Instruments
Company
GBS Commonwealth Co.,Ltd.
Model
LA01-0103
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800113396067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800113396067088001133960678800113396067

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

Regulatory Flags

DUNS number
694609156
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

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08800033811114The JASPER Spinal Fixation SystemL219-55352019-08-23
08800033811121The JASPER Spinal Fixation SystemL219-55402019-08-23
08800033811138The JASPER Spinal Fixation SystemL219-55452019-08-23
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08800033811183The JASPER Spinal Fixation SystemL219-60352019-08-23
08800033811190The JASPER Spinal Fixation SystemL219-60402019-08-23
08800033811206The JASPER Spinal Fixation SystemL219-60452019-08-23
08800033811213The JASPER Spinal Fixation SystemL219-60502019-08-23
08800033811220The JASPER Spinal Fixation SystemL219-60552019-08-23
08800033811237The JASPER Spinal Fixation SystemL219-60602019-08-23
08800033811244The JASPER Spinal Fixation SystemL219-65302019-08-23
08800033811251The JASPER Spinal Fixation SystemL219-65352019-08-23
08800033811268The JASPER Spinal Fixation SystemL219-65402019-08-23
08800033811275The JASPER Spinal Fixation SystemL219-65452019-08-23
08800033811282The JASPER Spinal Fixation SystemL219-65502019-08-23
08800033811299The JASPER Spinal Fixation SystemL219-65552019-08-23

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