Speed Shift

FDA UDI

Class II (US FDA UDI)

by Biomedical Enterprises, Inc.

Identity

Trade Name: Speed Shift FDA UDI
Generic Name: Orthopaedic bone staple, non-adjustable FDA UDI
Device Name: Speed Shift 20x20x20 Offset 12mm Implant FDA UDI
Model / Reference: SE-2020-12 FDA UDI
Description: Speed Shift 20x20x20 Offset 12mm Implant FDA UDI

Identifiers

Primary DI / UDI-DI: 00810633020500 FDA UDI
FDA Product Code: JDR FDA UDI
GMDN Term: Orthopaedic bone staple, non-adjustable 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 12 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI
Width — 20 Millimeter FDA UDI

Category: Orthopaedic bone staple, non-adjustable

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

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Also classified as Orthopaedic bone staple, non-adjustable.

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Speed Arc — Synthes · Class II
JAWS Nitinol Staple System — Paragon 28 · Class II
Speed — Synthes · Class II
GEO Staple System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Biomedical Enterprises, Inc.

Sources (1)

FDA UDI bb37733e-8d19-41ce-8cee-5a70c7714097 36 fields · synced May 30, 2026