Celling ART PRP 2-Step 120 Kit 1651-0005

GUDID 00817771028856

ART PRP 2-Step Processing Kit - 120

Celling Biosciences

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID00817771028856
NIH Device Record Keyd43d4a99-289a-40ef-9233-0727af6e7235
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelling ART PRP 2-Step 120 Kit
Version Model Number1651-0005
Catalog Number1651-0005
Company DUNS021560394
Company NameCelling Biosciences
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com
Phone512-206-0770
Emailcustomerservice@cellingbiosciences.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817771028856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-21
Device Publish Date2025-04-11

Devices Manufactured by Celling Biosciences

00817771027439 - ART BMC System Centrifuge2025-04-21 ART BMC System Centrifuge - Drucker
00817771027460 - ART BMC System Centrifuge2025-04-21 ART BMC System Centrifuge - LXY
00817771027484 - ART BMC System Centrifuge2025-04-21 ART BMC System Centrifuge - LXY2
00817771028788 - Celling ART BMC Plus 2025-04-21 ART BMC Plus Device
00817771028795 - Celling ART BMC 2025-04-21 ART BMC Processing Device
00817771028825 - Celling ART PRP 2-Step 60 Kit2025-04-21 ART PRP 2-Step Processing Kit - 60
00817771028849 - Celling Cardio Application Kit2025-04-21 Celling Cardio Application Kit
00817771028856 - Celling ART PRP 2-Step 120 Kit2025-04-21ART PRP 2-Step Processing Kit - 120
00817771028856 - Celling ART PRP 2-Step 120 Kit2025-04-21 ART PRP 2-Step Processing Kit - 120

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