FDA.report

ROMEO posterior osteosynthesis system

Primary DI
07640185341869
Brand
ROMEO posterior osteosynthesis system
Company
SpineArt SA
Model
SPE-US 00 50-N
Catalog number
SPE-US 00 50-N
Device description
Powerease Tap, Ø7mm
Published
2019-02-01
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
HWXTap, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640185341869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640185341869076401853418697640185341869

GMDN Terms

TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter7Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
483016148
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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