Stimulan® Pellets 600-48-010

GUDID 50601557100752

Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in

BIOCOMPOSITES LTD

Synthetic bone graft
Primary Device ID50601557100752
NIH Device Record Key163bc1fb-1d86-44aa-b60a-84c68007c95b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimulan® Pellets
Version Model Number600-48-010
Catalog Number600-48-010
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 Latexfalse
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

Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
Device Size Text, specify0
Width4.8 Millimeter
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
GS150601557100752 [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® Pellets]

50601557100752Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use.
50601557100516Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use.

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

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