Acumed

FDA UDI

Class I (US FDA UDI)

by Acumed Llc

Identity

Trade Name: ACUMED FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Acu-Loc 2 - 2.7mm LP Screw Caddy FDA UDI
Model / Reference: 80-3926 FDA UDI
Description: Acu-Loc 2 - 2.7mm LP Screw Caddy FDA UDI

Identifiers

Primary DI / UDI-DI: 10806378115370 FDA UDI
510(k) Number: K233311 FDA UDI
FDA Product Code: FSM FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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: Instrument tray, reusable

Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K233311 also covers:

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: Acumed Llc

Sources (1)

FDA UDI a9d5b332-d9df-40b6-8c85-d0254375e412 35 fields · synced May 31, 2026