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flamenco™ spinal fixation system

FDA UDI

Class II (US FDA UDI)

by Ulrich GmbH & Co. KG

Identity

Trade Name
flamenco™ spinal fixation system FDA UDI
Generic Name
Bone-screw internal spinal fixation system rod FDA UDI
Device Name
flamenco rod, ø 5.5 mm, length 130 mm FDA UDI
Model / Reference
CS 8012-130 FDA UDI
Description
flamenco rod, ø 5.5 mm, length 130 mm FDA UDI

Identifiers

Catalog Number
CS 8012-130 FDA UDI
Primary DI / UDI-DI
04052536021451 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

flamenco™ spinal fixation system by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulrich GmbH & Co. KG

Sources (1)

  • FDA UDI c0d91ac6-d226-48c9-b284-a11d5a72bd55 36 fields · synced Jun 1, 2026