Stimulan® Kit 600-010
GUDID 50601557101292
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 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 | 50601557101292 |
| NIH Device Record Key | a71cf74a-2f27-4daa-b07d-99197c5fde74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stimulan® Kit |
| Version Model Number | 600-010 |
| Catalog Number | 600-010 |
| 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 | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| 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 | 50601557101292 [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 | 2015-04-01 |
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 |
Trademark Results [Stimulan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIMULAN 78076491 not registered Dead/Abandoned |
Strata Lucida, Inc. 2001-07-30 |
 STIMULAN 75828548 2539013 Live/Registered |
Biocomposites Limited 1999-10-21 |
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