Eclipse PRP HC

FDA UDI

Class II (US FDA UDI)

by Eclipse, Inc.

Identity

Trade Name: Eclipse PRP HC FDA UDI
Generic Name: Haematological concentrate system FDA UDI
Device Name: Eclipse PRP HC Patient Kit - 22ml PRP Tube Only FDA UDI
Model / Reference: PRP2000-1 FDA UDI
Description: Eclipse PRP HC Patient Kit - 22ml PRP Tube Only FDA UDI

Identifiers

Catalog Number: PRP2000-1 FDA UDI
Primary DI / UDI-DI: 00853602008086 FDA UDI
FDA Product Code: ORG FDA UDI
GMDN Term: Haematological concentrate system 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

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

Dimensions & Sizes

Size: Weight — 63.9 Gram FDA UDI
Depth — 1.125 Inch FDA UDI
Width — 6.938 Inch FDA UDI
Height — 3.125 Inch FDA UDI

Category: Haematological concentrate system

Eclipse PRP HC by Eclipse, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Eclipse, Inc.

Sources (1)

FDA UDI d799851a-bd5b-4bf1-9871-de13bbb3ad73 36 fields · synced Jun 8, 2026