DEVICE: DELTA (04546540337306)

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Device Identifier (DI) Information

DELTA
70-06188
70-06188
Stryker Leibinger GmbH & Co. KG
04546540337306
GS1
1
DELTA 2.2MM CURVED PLATE 8 HOLE
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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
Craniofacial fixation plate, bioabsorbable A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.
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FDA Product Code

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Product Code Product Code Name
MAI FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: less than 49 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Number of Screw Holes: 8.0 Holes
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Device Status

In Commercial Distribution
September 24, 2015

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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