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Elite

FDA UDI

Class I (US FDA UDI)

by Biomedical Enterprises, Inc.

Identity

Trade Name
Elite FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
BME ELITE H-SERIES DRILLING TEMPLATE KIT FDA UDI
Model / Reference
EL-DTH FDA UDI
Description
BME ELITE H-SERIES DRILLING TEMPLATE KIT FDA UDI

Identifiers

Primary DI / UDI-DI
00810633022030 FDA UDI
510(k) Number
K150125 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
Lumen/Inner Diameter — 3.0 Millimeter FDA UDI

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

Elite 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.

Cleared under the same submission

K150125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomedical Enterprises, Inc.

Sources (1)

  • FDA UDI 3e8ca68e-f19b-4db0-bcf6-5c5267de484e 36 fields · synced May 31, 2026