Monet Nitro

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: MONET NITRO FDA UDI
Generic Name: Ceramic spinal interbody fusion cage FDA UDI
Device Name: Sterile, Monet Nitro ACIF Cage, 13 x 9, 9H, 8° FDA UDI
Model / Reference: S.213.2229 FDA UDI
Description: Sterile, Monet Nitro ACIF Cage, 13 x 9, 9H, 8° FDA UDI

Identifiers

Primary DI / UDI-DI: 00841732145825 FDA UDI
FDA Product Code: ODP FDA UDI
MAX FDA UDI
OVE FDA UDI
GMDN Term: Ceramic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ceramic spinal interbody fusion cage

Monet Nitro by CTL Medical Corporation — 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: CTL Medical Corporation

Sources (1)

FDA UDI 8dc4db09-edd1-4e65-b539-0de8fc19ca6f 33 fields · synced May 30, 2026