| Primary Device ID | M906ST10A0 |
| NIH Device Record Key | 3bf2eee3-ba14-4c97-851c-8eed1f480850 |
| Commercial Distribution Discontinuation | 2020-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Barricaid ACD Sizing Trial (10mm) |
| Version Model Number | 400877 |
| Catalog Number | ST-10-A |
| Company DUNS | 105722131 |
| Company Name | INTRINSIC THERAPEUTICS, INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com | |
| Phone | 781.932.0222 |
| info@in-thera.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M906ST10A0 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
[M906ST10A0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-31 |
| Device Publish Date | 2019-05-14 |
| M906WED1A0 - Barricaid ACD Retraction Wedge | 2023-05-03 Wedge to aid in retraction of the delivery tool following implantation of the Barricaid Anular Closure Device (ACD). Reusable we |
| M906KITD70 - Barricaid® ACD - Reusable Instruments Kit | 2021-02-23 Kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). Note |
| M906DMT10X11A0 - Defect Measurement Tool (10/11mm) | 2020-03-31 Stainless steel rod with specific sized ends (10 and 11 mm) for aiding in the measurement of soft tissue defects. |
| M906DMT12X13A0 - Defect Measurement Tool (12/13mm) | 2020-03-31 Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement of soft tissue defects. |
| M906DMT4X5A0 - Defect Measurement Tool (4/5mm) | 2020-03-31 Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the measurement of soft tissue defects. |
| M906DMT6X7A0 - Defect Measurement Tool (6/7mm) | 2020-03-31 Stainless steel rod with specific sized ends (6 and 7 mm) for aiding in the measurement of soft tissue defects. |
| M906DMT8X9A0 - Defect Measurement Tool (8/9mm) | 2020-03-31 Stainless steel rod with specific sized ends (8 and 9 mm) for aiding in the measurement of soft tissue defects. |
| M906EXTR1A0 - Barricaid ACD Extractor | 2020-03-31 Reusable extractor designed to facilitate Barricaid ACD removal, should it be necessary. |