PICASSO™ II MIS Spinal System

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: PICASSO™ II MIS Spinal System FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: PICASSO™ II MIS Spinal System Implant Tray, 7.5 Screws FDA UDI
Model / Reference: 019.8175 FDA UDI
Description: PICASSO™ II MIS Spinal System Implant Tray, 7.5 Screws FDA UDI

Identifiers

Catalog Number: 019.8175 FDA UDI
Primary DI / UDI-DI: 00841732109568 FDA UDI
510(k) Number: K140219 FDA UDI
FDA Product Code: MNI FDA UDI
NKB FDA UDI
MNH FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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: Instrument tray, reusable

PICASSO™ II MIS Spinal System by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 479716fa-840a-413d-ae62-fbc390e8ef9e 36 fields · synced Jun 8, 2026