Romeo 2 Mis Instrumentation

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name: ROMEO 2 MIS INSTRUMENTATION FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: Cannulated Nav. Tap FDA UDI
Model / Reference: NAV-IN 10 65-N FDA UDI
Description: Cannulated Nav. Tap FDA UDI

Identifiers

Catalog Number: NAV-IN 10 65-N FDA UDI
Primary DI / UDI-DI: 07640185341364 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Bone tap, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

Dimensions & Sizes

Size: Outer Diameter — 6.5 Millimeter FDA UDI

Category: Bone tap, reusable

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

Similar devices

Also classified as Bone tap, reusable.

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CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
PressON™ — NEXUS SPINE, L.L.C. · Class I
Insite — TORNIER, INC. · Class I
ReLine — Nuvasive, Inc. · Class I
Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I

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 d845ca97-9786-417d-86ec-5b8dc0b05f17 35 fields · synced May 31, 2026