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Surgical Instrument

FDA UDI

Class II (US FDA UDI)

by S.I.N. - Sistema DE Implante Nacional S.A.

Identity

Trade Name
SURGICAL INSTRUMENT FDA UDI
Generic Name
Surgical screwdriver, single-use, non-sterile FDA UDI
Device Name
DRIVER HANDPIECE UNITITE MORSE SHORT FDA UDI
Model / Reference
CTUM 20 FDA UDI
Description
DRIVER HANDPIECE UNITITE MORSE SHORT FDA UDI

Identifiers

Catalog Number
CTUM 20 FDA UDI
Primary DI / UDI-DI
07899995206428 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Surgical screwdriver, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, single-use, non-sterile

Surgical Instrument by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical screwdriver, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 7088ed76-6bd2-4cbb-8be4-5ccec8886915 34 fields · synced May 30, 2026