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 ID: 15060155711550
• NIH Device Record Key: b9f824ee-b6c2-4d96-8e37-31dfbb8fbdf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stimulan Rapid Cure 20cc (CHINA ONLY)
• Version Model Number: 620-020
• Company DUNS: 424382307
• Company Name: BIOCOMPOSITES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060155711550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141830

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-21
• Device Publish Date: 2022-11-12

Devices Manufactured by BIOCOMPOSITES LTD

• 15060155710492 - Bilok® ST Screw: 2023-09-18 The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phos
• 15060155710508 - Bilok® ST Screw: 2023-09-18 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® Screw: 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
• 15060155710577 - Bilok® Screw: 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
• 15060155710584 - Bilok® Screw: 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
• 15060155710607 - Bilok® Screw: 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
• 15060155710614 - Bilok® Screw: 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium
• 15060155710621 - Bilok® Screw: 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium