PICASSO MIS Spinal System

FDA UDI

Class I (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: PICASSO MIS Spinal System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Hex Driver, Cannulated, 1/4" Square QC, 4.0 Self-Retention FDA UDI
Model / Reference: 016.7100 FDA UDI
Description: Hex Driver, Cannulated, 1/4" Square QC, 4.0 Self-Retention FDA UDI

Identifiers

Primary DI / UDI-DI: 00841732108929 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

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

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USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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 I	Pending data

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Manufacturer

Manufacturer: CTL Medical Corporation

Sources (1)

FDA UDI d91399e6-56a9-49fc-9ec7-f3fa0f63d1c2 34 fields · synced Jun 1, 2026