Stimulan® Pellets 600-30-005

GUDID 50601557100516

Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.

BIOCOMPOSITES LTD

Synthetic bone graft

• Primary Device ID: 50601557100516
• NIH Device Record Key: ecbdd2a1-f266-4145-b70b-d5c4a1b0e797
• Commercial Distribution Discontinuation: 2020-03-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Stimulan® Pellets
• Version Model Number: 600-30-005
• Catalog Number: 600-30-005
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com

Device Dimensions

• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	50601557100516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001724

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2015-04-01

On-Brand Devices [Stimulan® Pellets]

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