Stimulan Rapid Cure 5cc (CHINA ONLY)

GUDID 15060155711536

(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 Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 15060155711536
• NIH Device Record Key: 239e3b0a-1c47-401d-9b9c-c504167c883c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stimulan Rapid Cure 5cc (CHINA ONLY)
• Version Model Number: 620-005
• 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	15060155711536 [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