DEVICE: Eclipse PRP HC (00853602008093)

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Device Record History
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Device Identifier (DI) Information
Eclipse PRP HC
PRP2000-1.Intl
In Commercial Distribution
PRP2000-1.Intl
ECLIPSE
00853602008093
GS1

1
969752364 *Terms of Use
Eclipse PRP HC Patient Kit - 22ml PRP Tube Only (International)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
47183 Haematological concentrate system
An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process.
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 [?]
BK110035 0
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 4 and 25 Degrees Celsius
Handling Environment Temperature: between 4 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Weight: 123.8 Gram
Depth: 1.125 Inch
Width: 6.938 Inch
Height: 3.125 Inch
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Device Record Status
88577d12-32b0-4468-a41b-bb0d49f5704b
November 05, 2018
1
October 04, 2018
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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
No Package DIs found
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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

[?]
No Customer Contact currently defined
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