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Amplifine

FDA UDI

Class II (US FDA UDI)

by Suneva Medical, Inc.

Identity

Trade Name
Amplifine FDA UDI
Generic Name
Autologous platelet-based product centrifuge tube FDA UDI
Device Name
Amplifine HD PRP convenience kit. Collection Set & Tourniquet, 10 pack FDA UDI
Model / Reference
BD Vacutainer and Torniquet FDA UDI
Description
Amplifine HD PRP convenience kit. Collection Set & Tourniquet, 10 pack FDA UDI

Identifiers

Catalog Number
SM-PRP-VT-10 FDA UDI
Primary DI / UDI-DI
00350224000158 FDA UDI
FDA Product Code
ORG FDA UDI
GMDN Term
Autologous platelet-based product centrifuge tube 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

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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Autologous platelet-based product centrifuge tube

Amplifine by Suneva Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autologous platelet-based product centrifuge tube.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suneva Medical, Inc.

Sources (1)

  • FDA UDI 14dd2cb6-05ed-4db8-acbd-2f959fe6bb6d 36 fields · synced Jun 8, 2026