DEVICE: Cervos Platelet Single PB (00850023741790)
Device Identifier (DI) Information
Cervos Platelet Single PB
CER-PRP-SINGLE-PB
In Commercial Distribution
CER-PRP-SINGLE-PB
RANFAC CORP.
CER-PRP-SINGLE-PB
In Commercial Distribution
CER-PRP-SINGLE-PB
RANFAC CORP.
CER-PRP-SINGLE-PB F/G, STERILE
PN: 76139-01M
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46923 | Haematological concentrate system preparation kit, platelet concentration |
A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ORG | Platelet And Plasma Separator For Bone Graft Handling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK200543 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit |
Special Storage Condition, Specify: Avoid excessive heat. Protect from freezing. Protect from direct sunlight. |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 40 Milliliter |
Device Record Status
75f40bbf-23e4-486b-be60-4feb59ad7dfc
June 08, 2023
1
May 31, 2023
June 08, 2023
1
May 31, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10850023741797 | 24 | 00850023741790 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
5085884400
info@ranfac.com
info@ranfac.com