DEVICE: NA (07613327176988)

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Device Identifier (DI) Information

NA
3102-1210
3102-1210
Stryker Corporation
07613327176988
GS1
1
Allograft DBM Plus Paste with Cancellous
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Device Characteristics

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

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 matrix implant, human-derived An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.
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FDA Product Code

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Product Code Product Code Name
MQV FILLER, BONE VOID, CALCIUM COMPOUND
MBP Filler, bone void, osteoinduction (w/o human growth factor)
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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: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Total Volume: 10.0 Cubic Centimeter
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Device Status

In Commercial Distribution
October 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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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