FDA.report

ORTHOFIX

Primary DI
18059015372908
Brand
ORTHOFIX
Company
ORTHOFIX SRL
Model
1
Catalog number
60003517
Device description
FITBONE TLN SCREW OVERLAY
Published
2024-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications

CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18059015372908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1805901537290818059015372908

GMDN Terms

TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags

DUNS number
438793622
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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