FDA.report

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033344162
Brand
4CIS® INSTRUMENT SYSTEM
Company
ALPHANOX CO.,LTD.
Model
5901-0208
Catalog number
5901-0208
Device description
4CIS® Torrey Pines Trial 0degree 32x11x14mm
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
08800033344162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800033344162088000333441628800033344162

GMDN Terms

TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. 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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