Bio V BP Bioactive Glass with DBM Putty - 5.0 cc BGP001-05

GUDID 00858686006065

Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser

AMEND SURGICAL, INC.

Cadaveric-donor/synthetic mineral bone graft
Primary Device ID00858686006065
NIH Device Record Keya3e49bb0-6d03-40ed-8376-85d706b10a30
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio V BP Bioactive Glass with DBM Putty - 5.0 cc
Version Model NumberBGP001-05
Catalog NumberBGP001-05
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

Customer Support Contacts

Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com
Phone8442813169
Emailsmathison@amendsurgical.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment HumidityBetween 1 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858686006065 [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 Date2017-11-10

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 cc2018-07-06 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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