Bio V BP Bioactive Glass with DBM Putty BGP001-01

GUDID 00858686006041

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 ID00858686006041
NIH Device Record Keyb2bc7ad9-c6e4-408b-9e9a-26a3736a80f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio V BP Bioactive Glass with DBM Putty
Version Model NumberBGP001-01
Catalog NumberBGP001-01
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 Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858686006041 [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 Date2018-01-12

On-Brand Devices [Bio V BP Bioactive Glass with DBM Putty]

00858686006072Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dis
00858686006041Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dis

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