DEVICE: MinerOss® X (00614950007868)

Device Identifier (DI) Information

MinerOss® X
MINX-CAN0.25GR
In Commercial Distribution
BH0021
ACE SURGICAL SUPPLY CO., INC.
00614950007868
GS1

1
042763706 *Terms of Use
MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 0.25G/.5CC
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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
Dental bone matrix implant, animal-derived A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
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FDA Product Code

[?]
Product Code Product Code Name
NPM BONE GRAFTING MATERIAL, ANIMAL SOURCE
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FDA Premarket Submission

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

Sterilization

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

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

[?]
Size Type Text
Weight: 0.25 Gram
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Device Record Status

2958ae4d-08bc-4997-864a-b52519fbaaa7
March 29, 2018
2
February 06, 2017
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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)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(508)588-3100 214
ritaknight@acesurgical.com
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