DEVICE: Sorrento Bone Graft Substitute Strip (12cc) (B064HB11500101)

Device Identifier (DI) Information

Sorrento Bone Graft Substitute Strip (12cc)
HB-115-0010
In Commercial Distribution

XENCO MEDICAL LLC
B064HB11500101
HIBCC

1
079282130 *Terms of Use
Sorrento Bone Graft Substitute Strip (12cc) 10cm x 2cm x .6cm (12cc) Alphatec Neocore Osteoconductive Matrix 100mm x 20mm x 6mm (12cc)
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Bone matrix implant, animal-derived, bioabsorbable A sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
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FDA Product Code

[?]
Product Code Product Code Name
MQV Filler, Bone Void, Calcium Compound
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ce04275a-6940-4327-96df-491d95648007
March 29, 2018
2
September 15, 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

[?]
858-202-1505
sarahdo@xencomedical.com
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