DEVICE: LYOPLANT ONLAY (04046963957841)

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Device Identifier (DI) Information

LYOPLANT ONLAY
1067050
1067050
Aesculap AG
04046963957841
GS1
1
LYOPLANT ONLAY 10.0X12.5CM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dura mater biomatrix implant A sterile device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant.
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FDA Product Code

[?]
Product Code Product Code Name
GXQ DURA SUBSTITUTE
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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
Device Size Text, specify: Width (mm) : 100.000 MM
Device Size Text, specify: Length : 125.000 MM
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Device Status

In Commercial Distribution
September 24, 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

[?]
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

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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