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Actinia®

FDA UDI

Class II (US FDA UDI)

by implantcast GmbH

Identity

Trade Name
Actinia® FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
broach handle easy lock GIS® right FDA UDI
Model / Reference
80049130 FDA UDI
Description
broach handle easy lock GIS® right FDA UDI

Identifiers

Primary DI / UDI-DI
04048844486808 FDA UDI
FDA Product Code
LZO FDA UDI
MEH FDA UDI
KWY FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3390 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument handle, non-torque-limiting

Actinia® by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
implantcast GmbH

Sources (1)

  • FDA UDI adf2ac90-eabc-4059-9842-7c18645ae072 33 fields · synced May 30, 2026