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Acumed

FDA UDI

Class I (US FDA UDI)

by Acumed Llc

Identity

Trade Name
ACUMED FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
Acu-Loc® Optional Screw Caddy Tray FDA UDI
Model / Reference
PL-2152 FDA UDI
Description
Acu-Loc® Optional Screw Caddy Tray FDA UDI

Identifiers

Primary DI / UDI-DI
10806378074691 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acumed Llc

Sources (1)

  • FDA UDI 25fe663d-7a58-4fcf-a528-b94b018a7480 35 fields · synced Jun 1, 2026