Stimulan® Pellets 600-48-010
GUDID 50601557100752
Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in
BIOCOMPOSITES LTD
Synthetic bone graft| Primary Device ID | 50601557100752 |
| NIH Device Record Key | 163bc1fb-1d86-44aa-b60a-84c68007c95b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stimulan® Pellets |
| Version Model Number | 600-48-010 |
| Catalog Number | 600-48-010 |
| 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 | false |
| 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
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| Device Size Text, specify | 0 |
| Width | 4.8 Millimeter |
| 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 | 50601557100752 [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 | 3 |
| Public Version Date | 2018-07-06 |
| 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. |
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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