Monet

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: MONET FDA UDI
Generic Name: Ceramic spinal interbody fusion cage FDA UDI
Device Name: STERILE, MONET ACIF Cage, Si3N4, W15xL11, 12°, H8mm FDA UDI
Model / Reference: S.213.2348 FDA UDI
Description: STERILE, MONET ACIF Cage, Si3N4, W15xL11, 12°, H8mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00841732165335 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

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Category: Ceramic spinal interbody fusion cage

Monet 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 1afe52ef-1615-4e44-a13e-a508588a1722 34 fields · synced May 31, 2026