NanoFUSE Bioactive Strip ASI209-10

GUDID 00858686006089

Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation

AMEND SURGICAL, INC.

Bone matrix implant, synthetic
Primary Device ID00858686006089
NIH Device Record Key2988d07f-a4a4-4544-9571-92da5b3d6b99
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoFUSE Bioactive Strip
Version Model Number50x25x7mm
Catalog NumberASI209-10
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 Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
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

Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter

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
GS100858686006089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-24
Device Publish Date2019-07-16

On-Brand Devices [NanoFUSE Bioactive Strip]

00858686006096Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantat
00858686006089Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantat

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