NanoFuse Bioactive Matrix - 5.0 cc NAN109-05

GUDID 00858686006010

Synthetic bone void filler containing DBM for orthopedic applications

AMEND SURGICAL, INC.

Cadaveric-donor/synthetic mineral bone graft
Primary Device ID00858686006010
NIH Device Record Key02b8ece6-e882-4cc4-901c-0d3c3bb76055
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoFuse Bioactive Matrix - 5.0 cc
Version Model NumberNAN109-05
Catalog NumberNAN109-05
Company DUNS080131031
Company NameAMEND SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100858686006010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-12

Devices Manufactured by AMEND SURGICAL, INC.

00858686006089 - NanoFUSE Bioactive Strip2019-07-24 Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation
00858686006096 - NanoFUSE Bioactive Strip2019-07-24 Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation
00858686006003 - NanoFuse Bioactive Matrix - 2.0 cc2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications
00858686006010 - NanoFuse Bioactive Matrix - 5.0 cc2018-07-06Synthetic bone void filler containing DBM for orthopedic applications
00858686006010 - NanoFuse Bioactive Matrix - 5.0 cc2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications
00858686006027 - NanoFuse Bioactive Matrix - 10.0 cc2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications
00858686006034 - NanoFuse Bioactive Matrix - 1.0 cc2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
00858686006041 - Bio V BP Bioactive Glass with DBM Putty2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
00858686006058 - Bio V BP Bioactive Glass with DBM Putty - 2.0 cc2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser

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