| Primary Device ID | H862PS2352 |
| NIH Device Record Key | 80af2082-df8f-4583-9f3d-6c67a7527673 |
| Commercial Distribution Discontinuation | 2019-09-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Posi-Stick Introducer Set |
| Version Model Number | PS2-35 |
| Catalog Number | PS2-35 |
| Company DUNS | 192559557 |
| Company Name | URESIL, LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-538-7374 |
| sales@uresil.com |
| Outer Diameter | 0.035 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H862PS2350 [Primary] |
| HIBCC | H862PS2351 [Package] Contains: H862PS2350 Package: Dispenser [10 Units] Discontinued: 2019-09-11 Not in Commercial Distribution |
| HIBCC | H862PS2352 [Package] Contains: H862PS2351 Package: Shipper [1 Units] Discontinued: 2019-09-11 Not 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 | 3 |
| Public Version Date | 2019-09-12 |
| Device Publish Date | 2016-08-30 |
| H862PS21S2 | Posi-Stick One-Step |
| H862PS21SNC2 | Posi-Stick One-Step |
| H862PS238SW2 | Posi-Stick Intro. Set w/PT Marker & .038" Super-Stiff GW |
| H862PS2382 | Posi-Stick Intro. Set w/PT Marker & .038" & .018" GW |
| H862PS235SW2 | Posi-Stick Intro. Set w/PT Marker & .035" Super-Stiff GW |
| H862PS2352 | Posi-Stick Intro. Set w/PT Marker & .035" & .018" GW |
| H862PS2182 | Posi-Stick .018" (.046mm) Guidewire |
| H862PS2002 | Posi-Stick Introducer Set w/PT Marker |
| 10817640020506 | Posi-Stick One-Step |