DEVICE: BioResorb® Macro Pore (04260310344058)

Device Identifier (DI) Information

BioResorb® Macro Pore
KE 19005505
In Commercial Distribution
KE 19005505
Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien
04260310344058
GS1

1
332192830 *Terms of Use
500-1000 µm; 5 x 0.5 ml
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16966 Synthetic bone graft
An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LYC Bone Grafting Material, Synthetic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050260 000
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Sterilization

Yes
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

[?]
Size Type Text
No Device Sizes
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Device Record Status

cc97d4e8-d6a8-4ff9-a3b3-ca421f2c47fd
July 06, 2018
3
September 25, 2015
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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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