Cervos Platelet Separator Triple Pack ACDA CER-PRP-TRIPLE-A

GUDID 10850023741919

CER-PRP-TRIPLE-A F/G, STERILE PN: 76148-01M

RANFAC CORP.

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Primary Device ID10850023741919
NIH Device Record Key66d736b3-01b1-4012-b2b5-5346adb20ff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervos Platelet Separator Triple Pack ACDA
Version Model NumberCER-PRP-TRIPLE-A
Catalog NumberCER-PRP-TRIPLE-A
Company DUNS121622872
Company NameRANFAC CORP.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com

Device Dimensions

Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850023741912 [Primary]
GS110850023741919 [Package]
Contains: 00850023741912
Package: CASE [20 Units]
In Commercial Distribution

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 Date2024-04-10
Device Publish Date2024-04-02

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10850023741919 - Cervos Platelet Separator Triple Pack ACDA2024-04-10CER-PRP-TRIPLE-A F/G, STERILE PN: 76148-01M
10850023741919 - Cervos Platelet Separator Triple Pack ACDA2024-04-10 CER-PRP-TRIPLE-A F/G, STERILE PN: 76148-01M
10850023741902 - MC-RAN-BZL2024-03-27 MC-RAN-BZL F/G, STERILE, P/N 74436-01M
10850023741889 - Bone Marrow Biopsy Needle, RBN-114-BS2024-03-21 Bone Marrow Biopsy Needle, RBN-114-BS PN 74434-01M
10850023741865 - CER-BN-84-SCR2024-01-08 CER-BN-84-SCR, F/G, STERILE, P/N 74432-01M
00850023741875 - CER-SUB-15902023-12-21 CER-SUB-1590, F/G, STERILE, P/N 74433-01M
10850023741803 - RAN-15282023-11-28 NEEDLE, RAN-1528, F/G, STERILE, RANFAC P/N 74421-01M
10850023741810 - RBN-1332023-11-28 NEEDLE, RBN-133, F/G, STERILE, RANFAC P/N 74425-01M
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