Stimulan Rapid Cure 20cc (CHINA ONLY)

GUDID 15060155711550

(CHINA ONLY) Stimulan® Calcium Sulphate (Stimulan® Rapid Cure) is provided sterile for single patient use The pack contains calcium sulphate powder and water. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to cure in situ or placed into a mould, the mixture sets to form Stimulan® pellets. The biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days.

BIOCOMPOSITES LTD

Synthetic bone graft
Primary Device ID15060155711550
NIH Device Record Keyb9f824ee-b6c2-4d96-8e37-31dfbb8fbdf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimulan Rapid Cure 20cc (CHINA ONLY)
Version Model Number620-020
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+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com
Phone+4401782338580
Emailinfo@biocomposites.com

Device Dimensions

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS115060155711550 [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 Date2022-11-21
Device Publish Date2022-11-12

Devices Manufactured by BIOCOMPOSITES LTD

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15060155710508 - Bilok® ST Screw2023-09-18 The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phos
15060155710546 - Bilok® Screw2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
15060155710577 - Bilok® Screw2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
15060155710584 - Bilok® Screw2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
15060155710607 - Bilok® Screw2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
15060155710614 - Bilok® Screw2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
15060155710621 - Bilok® Screw2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium

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