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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
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 40 mm FDA UDI
Model / Reference
CS 8009-80-40 FDA UDI
Description
flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 40 mm FDA UDI

Identifiers

Catalog Number
CS 8009-80-40 FDA UDI
Primary DI / UDI-DI
04052536087747 FDA UDI
FDA Product Code
KWP FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3070 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 15669387-37db-42a3-a44e-e4a5b3c84514 36 fields · synced May 31, 2026