Stimulan® Kit 600-005

GUDID 50601557101124

STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities

BIOCOMPOSITES LTD

Synthetic bone graft

• Primary Device ID: 50601557101124
• NIH Device Record Key: 477fa79e-3ee2-4f14-aaec-794ce8aabddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stimulan® Kit
• Version Model Number: 600-005
• Catalog Number: 600-005
• 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
• 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
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	50601557101124 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-04-15

On-Brand Devices [Stimulan® Kit]

• 50601557101292: STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfat
• 50601557101124: STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfat