Elos Accurate® Prosthetic Screwdriver 18mm

FDA UDI

Class I (US FDA UDI)

by Elos Medtech Pinol A/S

Identity

Trade Name: Elos Accurate® Prosthetic Screwdriver 18mm FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels. FDA UDI
Model / Reference: 68020507 FDA UDI
Description: The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels. FDA UDI

Identifiers

Catalog Number: 68020507 FDA UDI
Primary DI / UDI-DI: 05712821013675 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

Elos Accurate® Prosthetic Screwdriver 18mm by Elos Medtech Pinol A/S — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Elos Medtech Pinol A/S

Sources (1)

FDA UDI b34271f7-8feb-4039-8496-163ce7d8288d 35 fields · synced Jun 1, 2026