Romeo 2 Instrumentation

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name: ROMEO 2 INSTRUMENTATION FDA UDI
Generic Name: Bone awl, reusable FDA UDI
Device Name: PEDICLE PROBE SMALL FDA UDI
Model / Reference: ELL-IN 02 23-N FDA UDI
Description: PEDICLE PROBE SMALL FDA UDI

Identifiers

Catalog Number: ELL-IN 02 23-N FDA UDI
Primary DI / UDI-DI: 07640151088347 FDA UDI
FDA Product Code: KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Bone awl, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone awl, reusable

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spineart

Sources (1)

FDA UDI 81ec4fb9-a8ce-4db5-b714-626ca0d60c5c 34 fields · synced Jun 8, 2026