FDA.report

Vertefix II

Primary DI
06009696223186
Brand
Vertefix II
Company
ELITE SURGICAL SUPPLIES (PTY) LTD
Model
MI5100TX
Catalog number
MI5100TX
Device description
Alignment Rod 5.5 x 100mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06009696223186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06009696223186060096962231866009696223186

GMDN Terms

TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
568359710
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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