DEVICE: Biolox® delta (04046963973001)

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Device Identifier (DI) Information

Biolox® delta
NK750D
NK750D
Aesculap AG
04046963973001
GS1
1
BIOLOX DELTA PROSTH.HEAD 12/14 40MM S
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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
Ceramic femoral head prosthesis A sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
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FDA Product Code

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Product Code Product Code Name
OQG Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Taper Size : 12/14
Device Size Text, specify: Outer diameter (mm) : 40.000 MM
Device Size Text, specify: Figure / Size : Size S
Device Size Text, specify: Neck length : - 4.0
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Device Status

In Commercial Distribution
November 11, 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888)229-3002
setworld_orders@aesculap.com
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