Stimulan Kit 10cc (CHINA ONLY)

Basic Information

• Brand Name: Stimulan Kit 10cc (CHINA ONLY)
• Primary DI: 15060155711574
• Version / Model: 600-010
• Company Name: BIOCOMPOSITES LTD
• Labeler DUNS: 424382307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-12
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: 6bbad440-80ff-4495-be05-c83bc70e4e55

Device Description

(CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be injected, 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 when used in accordance with the device labelling.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	888.3045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060155711574	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141830	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10cc

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 45 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 39 – 113 Degrees Fahrenheit