CER-PRP-JUVA CER-PRP-JUVA

GUDID 10850023741896

CER-PRP-JUVA F/G, STERILE PN: 76145-01M

RANFAC CORP.

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Primary Device ID10850023741896
NIH Device Record Key059e3c18-623f-4cc0-a51a-dd9f6129b9c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCER-PRP-JUVA
Version Model NumberCER-PRP-JUVA
Catalog NumberCER-PRP-JUVA
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Dimensions

Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 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 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850023741899 [Primary]
GS110850023741896 [Package]
Contains: 00850023741899
Package: Case [12 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 Date2024-05-23
Device Publish Date2024-05-15

Devices Manufactured by RANFAC CORP.

10850023741896 - CER-PRP-JUVA 2024-05-23CER-PRP-JUVA F/G, STERILE PN: 76145-01M
10850023741896 - CER-PRP-JUVA 2024-05-23 CER-PRP-JUVA F/G, STERILE PN: 76145-01M
00850023741929 - CER-JUVA-BD ASSEMBLY2024-05-23 CER-JUVA-BD Assembly PN 69014-01M
00850023741936 - CER-PRP-JUVA-KIT2024-05-23 CER-PRP-JUVA-KIT F/G, STERILE PN: 76152-01M
10850023741957 - MC-RAN-BZL-8C2024-05-14 MC-RAN-BZL-8C F/G, STERILE, P/N 74431-01M
10850023741940 - MC-RAN-BZL-8C2024-04-12 MC-RAN-BZL-8C F/G, STERILE, P/N 74438-01M
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
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