FDA.report

Spine Instruments

Primary DI
08033860020095
Brand
Spine Instruments
Company
Medacta International SA
Model
03.52.10.0465
Device description
K-Wire Ø1.5x460mm - Sharp NiTi - Marking - STERILE
Published
2021-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDFGuide, Needle, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033860020095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033860020095080338600200958033860020095

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.

Device Sizes

TypeValueUnit
Length460Millimeter
Outer Diameter1.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+39053527850support@biopsybell.it

Regulatory Flags

DUNS number
488227125
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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