| Primary Device ID | B487EXITN9245750 |
| NIH Device Record Key | 48913731-21f8-4d85-a28f-1a5e14f525dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ITN Implant |
| Version Model Number | EXITN924575 |
| Catalog Number | EXITN924575 |
| Company DUNS | 116722111 |
| Company Name | EXSOMED CORPORATION |
| 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 | 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 |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B487EXITN9245750 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-16 |
| Device Publish Date | 2018-04-06 |
| B487EXITN9245750 | ITN Implant is a stainless steel bone screw |
| B487EXITN9245650 | ITN Implant is a stainless steel bone screw |
| B487EXITN9245550 | ITN Implant is a stainless steel bone screw |
| B487EXITN9245500 | ITN Implant is a stainless steel bone screw |
| B487EXITN9245450 | ITN Implant is a stainless steel bone screw |
| B487EXITN9245400 | ITN Implant is a stainless steel bone screw |
| B487EXITN9245350 | ITN Implant is a stainless steel bone screw |