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Acumed

FDA UDI

Class II (US FDA UDI)

by Acumed Llc

Identity

Trade Name
ACUMED FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
26.0mm, Standard Acutrak 2® Bone Screw FDA UDI
Model / Reference
AT2-S26 FDA UDI
Description
26.0mm, Standard Acutrak 2® Bone Screw FDA UDI

Identifiers

Primary DI / UDI-DI
10806378057328 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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: Orthopaedic bone screw, non-bioabsorbable, non-sterile

ACUMED is a reliable and high-quality medical device designed for internal orthopaedic fracture fixation, providing effective and safe treatment options for patients. Our bone screws are made from implant-grade materials and are available in various threading options to accommodate different surgical needs.

Similar devices

Also classified as Orthopaedic bone 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 4abbddf7-5250-4040-b362-b6349f865f59 34 fields · synced Jul 11, 2026