| Primary Device ID | 30858769006532 |
| NIH Device Record Key | 60c1171c-3855-48ec-95db-567dccfe4412 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeSept RF Transseptal Guidewire |
| Version Model Number | SSRF135R |
| Catalog Number | SSRF135R |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858769006531 [Primary] |
| GS1 | 30858769006532 [Package] Contains: 00858769006531 Package: Box [5 Units] In Commercial Distribution |
| DXF | Catheter, Septostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-31 |
| Device Publish Date | 2026-03-23 |
| 30858769006556 | 0.035" x 230cm x Retention Transseptal Wires in Five Unit Box |
| 30858769006549 | 0.035" x 230cm x J-Curve Transseptal Wires in Five Unit Box |
| 30858769006532 | 0.035" x 180cm x Retention Transseptal Wires in Five Unit Box |
| 30858769006525 | 0.035" x 180cm x J-Curve Transseptal Wires in Five Unit Box |
| 00858769006517 | 0.032" x 230cm x Retention Transseptal Wires in Five Unit Box |
| 30858769006501 | 0.032" x 230cm x J-Curve Transseptal Wires in Five Unit Box |
| 00858769006494 | 0.032" x 180cm x Retention Transseptal Wires in Five Unit Box |
| 30858769006488 | 0.032" x 180cm x J-Curve Transseptal Wires in Five Unit Box |