| Primary Device ID | 07630031755391 |
| NIH Device Record Key | 4d0a2511-0f01-4f54-b19d-dbc0517e67e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants |
| Version Model Number | SLA Roxolid BL |
| Catalog Number | 061.8516 |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031755391 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-09 |
| Device Publish Date | 2022-03-01 |
| 07630031755438 | BLX Implant, Ø 6.5mm WB, SLA® 16mm, Roxolid® |
| 07630031755421 | BLX Implant, Ø 6.5mm WB, SLA® 14mm, Roxolid® |
| 07630031755414 | BLX Implant, Ø 6.5mm WB, SLActive® 16mm, Roxolid® |
| 07630031755407 | BLX Implant, Ø 6.5mm WB, SLActive® 14mm, Roxolid® |
| 07630031755391 | BLX Implant, Ø 5.5mm WB, SLA® 16mm, Roxolid® |
| 07630031755384 | BLX Implant, Ø 5.5mm WB, SLA® 14mm, Roxolid® |
| 07630031755377 | BLX Implant, Ø 5.5mm WB, SLActive® 16mm, Roxolid® |
| 07630031755360 | BLX Implant, Ø 5.5mm WB, SLActive® 14mm, Roxolid® |
| 07630031743848 | BLX Implant, Ø 5.0mm WB, SLA® 18mm, Roxolid® |