| Primary Device ID | 06438394007482 |
| NIH Device Record Key | 63990d6f-6d1b-4b03-9633-66379556459b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ActivaScrew™ Interference |
| Version Model Number | B-AI-0828 |
| Catalog Number | B-AI-0828 |
| Company DUNS | 368715301 |
| Company Name | Bioretec Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Width | 8 Millimeter |
| Length | 28 Millimeter |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438394007482 [Primary] |
| HIBCC | E302BAI08289 [Previous] |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-04 |
| Device Publish Date | 2026-01-27 |
| E302BAI10339 | ActivaScrew™ Interference 10 x 33 mm |
| E302BAI10309 | ActivaScrew™ Interference 10 x 30 mm |
| E302BAI10289 | ActivaScrew™ Interference 10 x 28 mm |
| E302BAI10249 | ActivaScrew™ Interference 10 x 24 mm |
| E302BAI09339 | ActivaScrew™ Interference 9 x 33 mm |
| E302BAI09309 | ActivaScrew™ Interference 9 x 30 mm |
| E302BAI09289 | ActivaScrew™ Interference 9 x 28 mm |
| E302BAI09249 | ActivaScrew™ Interference 9 x 24 mm |
| E302BAI09209 | ActivaScrew™ Interference 9 x 20 mm |
| E302BAI08339 | ActivaScrew™ Interference 8 x 33 mm |
| E302BAI08309 | ActivaScrew™ Interference 8 x 30 mm |
| E302BAI08289 | ActivaScrew™ Interference 8 x 28 mm |
| E302BAI08249 | ActivaScrew™ Interference 8 x 24 mm |
| E302BAI08209 | ActivaScrew™ Interference 8 x 20 mm |
| E302BAI07309 | ActivaScrew™ Interference 7 x 30 mm |
| E302BAI07269 | ActivaScrew™ Interference 7 x 26 mm |
| E302BAI07249 | ActivaScrew™ Interference 7 x 24 mm |
| E302BAI07209 | ActivaScrew™ Interference 7 x 20 mm |
| E302BAI06269 | ActivaScrew™ Interference 6 x 26 mm |
| E302BAI06209 | ActivaScrew™ Interference 6 x 20 mm |
| E302BAI06159 | ActivaScrew™ Interference 6 x 15 mm |
| E302BAI05209 | ActivaScrew™ Interference 5 x 20 mm |
| E302BAI05159 | ActivaScrew™ Interference 5 x 15 mm |
| E302BAI05109 | ActivaScrew™ Interference 5 x 10 mm |
| E302BAI04209 | ActivaScrew™ Interference 4 x 20 mm |
| E302BAI04159 | ActivaScrew™ Interference 4 x 15 mm |
| E302BAI04109 | ActivaScrew™ Interference 4 x 10 mm |
| 06438394007451 | ActivaScrew™ Interference 7 x 26 mm |
| 06438394007390 | ActivaScrew™ Interference 5 x 20 mm |
| 06438394007345 | ActivaScrew™ Interference 4 x 15 mm |
| 06438394007321 | ActivaScrew™ Interference 4 x 10 mm |
| 06438394007512 | ActivaScrew™ Interference 9 x 24 mm |
| 06438394007482 | ActivaScrew™ Interference 8 x 28 mm |
| 06438394007475 | ActivaScrew™ Interference 8 x 24 mm |
| 06438394007468 | ActivaScrew™ Interference 7 x 30 mm |
| 06438394007437 | ActivaScrew™ Interference 7 x 20 mm |
| 06438394007383 | ActivaScrew™ Interference 5 x 15 mm |
| 06438394007369 | ActivaScrew™ Interference 4 x 20 mm |