Stimulan® Dispenser 600-30-s1
GUDID 50601557100998
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 | 50601557100998 |
| NIH Device Record Key | 08ac819a-9e9c-4bc5-8ce8-492c0d3cf113 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stimulan® Dispenser |
| Version Model Number | 600-30-s1 |
| Catalog Number | 600-30-s1 |
| 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
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
| Device Size Text, specify | 0 |
| Width | 3 Millimeter |
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 | 50601557100998 [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 | 2015-05-31 |
Devices Manufactured by BIOCOMPOSITES LTD
| 15060155712021 - Synicem Hip Spacer 40C | 2025-07-16 Synicem 40C Hip Spacer. Charnley Stem Type, 40mm Head, 127 mm Stem Length. Temporary implant which main function is to preserve |
| 15060155712038 - Synicem Hip Spacer 48C | 2025-07-16 Charnley Stem Type, 48mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space duri |
| 15060155712045 - Synicem Hip Spacer 56C | 2025-07-16 Charnley Stem Type, 56mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space duri |
| 15060155712052 - Synicem Hip Spacer 40CXL | 2025-07-16 Charnley Stem Type, 40mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space duri |
| 15060155712069 - Synicem Hip Spacer 48CXL | 2025-07-16 Charnley Stem Type, 48mm Head, 250mm Stem Length Temporary implant which main function is to preserve the articular space durin |
| 15060155712076 - Synicem Hip Spacer 56CXL | 2025-07-16 Charnley Stem Type, 56mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space duri |
| 15060155712083 - Synicem Hip Spacer 48M | 2025-07-16 Muller Stem Type, 48mm Head, 120 mm Stem Length. Temporary implant which main function is to preserve the articular space during |
| 15060155712090 - Synicem Hip Spacer 56M | 2025-07-16 Muller Stem Type, 56mm Head, 127mm Stem Length. Temporary implant which main function is to preserve the articular space during |
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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