DEVICE: Cervos Platelet Separator Triple Pack with Blood Draw and ACD-A (00857878007408)

Device Identifier (DI) Information

Cervos Platelet Separator Triple Pack with Blood Draw and ACD-A
CER-PRP-60
In Commercial Distribution
CER-PRP-60
RANFAC CORP.
00857878007408
GS1

1
121622872 *Terms of Use
CER-PRP-60 KIT F/G, STERILE PN: 76112-01M
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ORG Platelet And Plasma Separator For Bone Graft Handling
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK200543 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Avoid excessive heat. Protect from freezing. Protect from direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 120 Milliliter
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Device Record Status

1451ea3a-3f54-490a-be12-b7fb5a7f5f46
August 22, 2022
1
August 12, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10857878007405 1 00857878007408 In Commercial Distribution Inner Pack
20857878007402 12 10857878007405 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
5085884400
info@ranfac.com
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