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Acumed

FDA UDI

Class II (US FDA UDI)

by Acumed Llc

Identity

Trade Name
ACUMED FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
12 Hole Dorsolateral Midshaft Radius Plt FDA UDI
Model / Reference
70-0077 FDA UDI
Description
12 Hole Dorsolateral Midshaft Radius Plt FDA UDI

Identifiers

Primary DI / UDI-DI
10806378032776 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

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

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acumed Llc

Sources (1)

  • FDA UDI e541f172-2e80-4c2d-b2c4-eaf0758ed614 34 fields · synced May 30, 2026