← Back to catalogue

Speed Triad

FDA UDI

Class I (US FDA UDI)

by Biomedical Enterprises, Inc.

Identity

Trade Name
Speed Triad FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Speed Triad Drill Kit FDA UDI
Model / Reference
DK-200T FDA UDI
Description
Speed Triad Drill Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00810633021651 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use 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

Yes

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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.0 Millimeter FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

Speed Triad by Biomedical Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomedical Enterprises, Inc.

Sources (1)

  • FDA UDI 1d685c47-fd3a-4a06-b0ee-178a59d00c41 35 fields · synced May 30, 2026