Stimulan® Kit 600-010

GUDID 50601557101292

STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities

BIOCOMPOSITES LTD

Synthetic bone graft
Primary Device ID50601557101292
NIH Device Record Keya71cf74a-2f27-4daa-b07d-99197c5fde74
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimulan® Kit
Version Model Number600-010
Catalog Number600-010
Company DUNS424382307
Company NameBIOCOMPOSITES LTD
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS150601557101292 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-04-01

On-Brand Devices [Stimulan® Kit]

50601557101292STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfat
50601557101124STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfat

Trademark Results [Stimulan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STIMULAN
STIMULAN
78076491 not registered Dead/Abandoned
Strata Lucida, Inc.
2001-07-30
STIMULAN
STIMULAN
75828548 2539013 Live/Registered
Biocomposites Limited
1999-10-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.