Biosteon® IntraLine® 3910-200-081
GUDID 35060155711165
The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which wi
BIOCOMPOSITES LTD
Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw| Primary Device ID | 35060155711165 |
| NIH Device Record Key | 07164c9a-0b0d-4365-8105-2cc288d31d5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biosteon® IntraLine® |
| Version Model Number | 3910-200-081 |
| Catalog Number | 3910-200-081 |
| 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 | |
| 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 | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
| Width | 5.5 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060155711161 [Primary] |
| GS1 | 35060155711165 [Package] Contains: 15060155711161 Package: Sleeve [5 Units] In Commercial Distribution |
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-06-30 |
On-Brand Devices [Biosteon® IntraLine®]
| 15060155711215 | The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single |
| 35060155711202 | The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a s |
| 15060155711192 | The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single us |
| 15060155711185 | The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single |
| 15060155711178 | The Biosteon® IntraLine® 5.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a s |
| 35060155711165 | The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single us |
Trademark Results [Biosteon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSTEON 76266609 2648714 Live/Registered |
Biocomposites Ltd 2001-06-04 |
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