| Primary Device ID | 30858769006259 |
| NIH Device Record Key | 7f9ca2c7-cb09-4158-a01d-0278c958c9b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transseptal Needle |
| Version Model Number | TSN198 |
| Catalog Number | TSN198 |
| 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 | 00858769006258 [Primary] |
| GS1 | 30858769006259 [Package] Contains: 00858769006258 Package: Box [5 Units] In Commercial Distribution |
| DRC | Trocar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-31 |
| Device Publish Date | 2018-11-28 |
| 30858769006259 | 98cm Transseptal Needle Curve 1 |
| 30858769006242 | 89cm Transseptal Needle Curve 1 |
| 00858769006234 | 71cm Transseptal Needle Curve 1 |
| 30858769006211 | 98cm Transseptal Needle Curve 0 |
| 30858769006204 | 89cm Transseptal Needle Curve 0 |
| 30858769006198 | 71cm Transseptal Needle Curve 0 |