| Primary Device ID | EBES8400090 |
| NIH Device Record Key | acf6bfe7-b9f9-44df-a588-1bff9bfa674e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rutter Stent |
| Version Model Number | 840009 |
| Catalog Number | 840009 |
| Company DUNS | 131855157 |
| Company Name | BOSTON MEDICAL PRODUCTS, INC. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Length | 93 Millimeter |
| Outer Diameter | 9 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBES8400090 [Primary] |
| HIBCC | EBES8400091 [Package] Package: Carton [1 Units] In Commercial Distribution |
| FWN | Prosthesis, Larynx (Stents And Keels) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-20 |
| EBES8400150 | Size: 15 mm; Type: Radiopaque |
| EBES8400140 | Size: 14 mm; Type: Radiopaque |
| EBES8400130 | Size: 13 mm; Type: Radiopaque |
| EBES8400120 | Size: 12 mm; Type: Radiopaque |
| EBES8400110 | Size: 11 mm; Type: Radiopaque |
| EBES8400100 | Size: 10 mm; Type: Radiopaque |
| EBES8400090 | Size: 9 mm; Type: Radiopaque |
| EBES8400080 | Size: 8 mm; Type: Radiopaque |
| EBES8400070 | Size: 7 mm; Type: Radiopaque |
| EBES8400060 | Size: 6 mm; Type: Radiopaque |
| 14063107101738 | Size: 15 mm; Type: Radiopaque |
| 14063107101721 | Size: 14 mm; Type: Radiopaque |
| 14063107101714 | Size: 13 mm; Type: Radiopaque |
| 14063107101707 | Size: 12 mm; Type: Radiopaque |
| 14063107101691 | Size: 11 mm; Type: Radiopaque |
| 14063107101684 | Size: 10 mm; Type: Radiopaque |
| 14063107101677 | Size: 9 mm; Type: Radiopaque |
| 14063107101660 | Size: 8 mm; Type: Radiopaque |
| 14063107101653 | Size: 7 mm; Type: Radiopaque |
| 14063107101646 | Size: 6 mm; Type: Radiopaque |