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
| 15060155710492 - Bilok® ST Screw | 2023-09-18 The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phos |
| 15060155710508 - Bilok® ST Screw | 2023-09-18 The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phos |
| 15060155710546 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710577 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710584 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710607 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710614 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710621 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
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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