| Primary Device ID | 30858769006297 |
| NIH Device Record Key | 9fccf05a-db13-4a65-a6c5-1cfb3e5e14d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transseptal Introducer |
| Version Model Number | TSIL0881 |
| Catalog Number | TSIL0881 |
| Company DUNS | 081047841 |
| Company Name | PPMDM |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858769006296 [Primary] |
| GS1 | 30858769006297 [Package] Contains: 00858769006296 Package: Box [5 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-11-09 |
| 30858769006341 | 8.5F x 81cm Transseptal Introducer Set L1 Curve |
| 30858769006334 | 8.5F x 81cm Transseptal Introducer Set L0 Curve |
| 30858769006327 | 8.5F x 63cm Transseptal Introducer Set L1 Curve |
| 30858769006310 | 8.5F x 63cm Transseptal Introducer Set L0 Curve |
| 30858769006303 | 8F x 81cm Transseptal Introducer Set L1 Curve |
| 30858769006297 | 8F x 81cm Transseptal Introducer Set L0 Curve |
| 30858769006280 | 8F x 63cm Transseptal Introducer Set L1 Curve |
| 30858769006273 | 8F x 63cm Transseptal Introducer Set L0 Curve |