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Romeo 2 Pad Instrumentation

FDA UDI

Class I (US FDA UDI)

by Spineart

Identity

Trade Name
ROMEO 2 PAD INSTRUMENTATION FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Rasp Trial 08 FDA UDI
Model / Reference
SPE-IN 01 50-N FDA UDI
Description
Rasp Trial 08 FDA UDI

Identifiers

Catalog Number
SPE-IN 01 50-N FDA UDI
Primary DI / UDI-DI
07640185341203 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Romeo 2 Pad Instrumentation by Spineart — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA UDI 71a8f501-bc63-4cdd-8b3f-00283413ac3f 34 fields · synced May 31, 2026