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PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System

FDA UDI

Class II (US FDA UDI)

by EmCyte Corporation

Identity

Trade Name
PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Model / Reference
GS60-SP FDA UDI

Identifiers

Catalog Number
GS60-SP FDA UDI
Primary DI / UDI-DI
00855306003695 FDA UDI
FDA Product Code
ORG FDA UDI
GMDN Term
Haematological concentrate system preparation kit, platelet concentration 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

No

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Haematological concentrate system preparation kit, platelet concentrationHaematological concentrate system preparation kit, bone marrow concentration

PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System by EmCyte Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Haematological concentrate system preparation kit, bone marrow concentration.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EmCyte Corporation

Sources (1)

  • FDA UDI f2f8c80f-81f1-4cb5-833b-aee94b85ed6e 35 fields · synced Jun 9, 2026