FDA.report

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033343967
Brand
4CIS® INSTRUMENT SYSTEM
Company
ALPHANOX CO.,LTD.
Model
5901-0454
Catalog number
5901-0454
Device description
4CIS® Penfield Bayonet
Published
2019-12-25
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

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800033343967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800033343967088000333439678800033343967

GMDN Terms

TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687844241
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
088000333859814CIS VANE SPINE SYSTEM4712-75604712-75602015-09-24
088000333859984CIS VANE SPINE SYSTEM4712-75654712-75652015-09-24
088000333860014CIS VANE SPINE SYSTEM4712-75704712-75702015-09-24
088000333860184CIS VANE SPINE SYSTEM4712-75754712-75752015-09-24
088000333860494CIS VANE SPINE SYSTEM4713-55254713-55252015-09-24
088000333860564CIS VANE SPINE SYSTEM4713-55304713-55302015-09-24
088000333860634CIS VANE SPINE SYSTEM4713-55354713-55352015-09-24
088000333860704CIS VANE SPINE SYSTEM4713-55404713-55402015-09-24
088000333860874CIS VANE SPINE SYSTEM4713-55454713-55452015-09-24
088000333860944CIS VANE SPINE SYSTEM4713-55504713-55502015-09-24
088000333861004CIS VANE SPINE SYSTEM4713-55554713-55552015-09-24
088000333861174CIS VANE SPINE SYSTEM4713-55604713-55602015-09-24
088000333861244CIS VANE SPINE SYSTEM4713-55654713-55652015-09-24
088000333861314CIS VANE SPINE SYSTEM4713-55704713-55702015-09-24
088000333861484CIS VANE SPINE SYSTEM4713-55754713-55752015-09-24
088000333861624CIS VANE SPINE SYSTEM4713-65254713-65252015-09-24
088000333861794CIS VANE SPINE SYSTEM4713-65304713-65302015-09-24
088000333861864CIS VANE SPINE SYSTEM4713-65354713-65352015-09-24
088000333861934CIS VANE SPINE SYSTEM4713-65404713-65402015-09-24
088000333862094CIS VANE SPINE SYSTEM4713-65454713-65452015-09-24

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