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BioHorizons

FDA UDI

Class II (US FDA UDI)

by Biohorizons Implant Systems Inc.

Identity

Trade Name
BioHorizons FDA UDI
Generic Name
Centrifuge rotor, ultracentrifuge FDA UDI
Device Name
IntraSpin Rotor, 110v & 220v FDA UDI
Model / Reference
BROTORZ FDA UDI
Description
IntraSpin Rotor, 110v & 220v FDA UDI

Identifiers

Primary DI / UDI-DI
00847236015886 FDA UDI
FDA Product Code
ORG FDA UDI
GMDN Term
Centrifuge rotor, ultracentrifuge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9245 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Centrifuge rotor, ultracentrifuge

BioHorizons by Biohorizons Implant Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

BK120048 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biohorizons Implant Systems Inc.

Sources (1)

  • FDA UDI ad8b2934-1812-4d44-b6de-3ec7f91b3c34 34 fields · synced May 30, 2026