DEVICE: NuOss DS (00614950009053)

Device Identifier (DI) Information

NuOss DS
5099025
In Commercial Distribution
5099025
ACE SURGICAL SUPPLY CO., INC.
00614950009053
GS1

1
042763706 *Terms of Use
NUOSS DS CANCELLOUS .25CC PARTICLE SIZE .25-1MM SYRINGE
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47968 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.
Active true
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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 [?]
K170541 000
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
Device Size Text, specify: 0.25 cc
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Device Record Status

32060cd9-4ef5-4516-b798-987fe8c375c3
July 06, 2018
3
July 19, 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
No
Yes
No
No CLOSE

Customer Contact

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