DEVICE: Ostene (05413760467450)

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Device Identifier (DI) Information

Ostene
1503831
1503831
Apatech Ltd
05413760467450
GS1
1
Bone Hemostasis Material - 3.5g
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Bone wax, synthetic A sterile, implantable device in the form of a sterile wax-like, putty-like, or paste material designed to stop bone bleeding by the creation of a physical barrier along the edges of bone that has been damaged by trauma or cut during a surgical procedure. When placed on the bone under moderate pressure it plugs the vascular openings in the bone and prevents further bleeding. It is typically made from biocompatible/bioabsorbable synthetic substances (e.g., water-soluble copolymers); its stickiness may be increased by warming and by additional handling and manipulation.
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FDA Product Code

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Product Code Product Code Name
MTJ WAX,BONE
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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
Special Storage Condition, Specify: OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight.
Storage Environment Temperature: between 0 and 32 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 3.5 Gram
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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
55413760467455 10 05413760467450 In Commercial Distribution CASE
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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
No
No CLOSE

Customer Contact

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+1(800)933-0303
Medinfo_medproducts@baxter.com
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