DEVICE: BioHorizons (00847236015893)

Device Identifier (DI) Information

BioHorizons
BTUBEHOLDZ
In Commercial Distribution

BIOHORIZONS IMPLANT SYSTEMS, INC
00847236015893
GS1

1
967279910 *Terms of Use
IntraSpin Tube Holder Replacement
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
15682 Centrifuge bucket/tube holder
A cylindrical or bucket-like device designed as a removable component of a centrifuge rotor head intended to safely contain (hold) a laboratory test tube or centrifuge tube containing a sample/specimen while the centrifuge is being operated at high speeds. It is typically made of metal or a strong synthetic polymer, has one or multiple positions for holding the sample/specimen tubes, and is open at the proximal end for their insertion. A protective screw-top cap or lid may be included to contain the contents of one or more sample/specimen tubes in the event of breakage. This is a reusable 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 [?]
BK120048 0
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

175178e0-1330-467c-b4ab-dc2eb24095cb
January 19, 2021
1
January 11, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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