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3.5 mm Hex Head Screwdriver

FDA UDI

Class II (US FDA UDI)

by Ecential Robotics

Identity

Trade Name
3.5 mm Hex Head Screwdriver FDA UDI
Generic Name
Surgical screwdriver, reusable FDA UDI
Model / Reference
A40043 FDA UDI

Identifiers

Primary DI / UDI-DI
03701311500735 FDA UDI
510(k) Number
K221028 FDA UDI
K231886 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Surgical screwdriver, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

3.5 mm Hex Head Screwdriver by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical screwdriver, reusable.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ecential Robotics

Sources (1)

  • FDA UDI 775d23fc-6090-4ebe-a4e3-a2efdf89de30 34 fields · synced May 30, 2026