| Primary Device ID | B16080141 |
| NIH Device Record Key | a00a4914-af97-4767-80dd-803b613d236e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procedure Product Torque Device |
| Version Model Number | 8014 |
| Company DUNS | 151507563 |
| Company Name | PROCEDURE PRODUCTS, INC. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B16080141 [Primary] |
| DQX | Wire, Guide, 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 | 2018-03-29 |
| Device Publish Date | 2018-02-12 |
| B1601006B1 - Freedom Syringe | 2020-09-08 Freedom Syringe, 6cc Blue Plunger |
| B160B10R0721 - Procedure Products Lines | 2020-05-01 HIGH PRESSURE BRAIDED SWIVEL LINE, 10" |
| B1601001R1 - Freedom Syringe | 2020-03-18 Freedom Syringe, 01cc Red Plunger |
| B1601003G1 - Freedom Syringe | 2020-03-18 Freedom Syringe, 03cc Green Plunger |
| B1601010B1 - Freedom Syringe | 2020-03-18 Freedom Syringe, 10cc Blue Plunger |
| B1601020W1 - Freedom Syringe | 2020-03-18 Freedom Syringe, 20cc White Plunger |
| B1603118451 - Procedure Products Needle | 2020-03-18 NEEDLE, W/O BASEPLATE, 11CM 18g |
| B1605320Y1 - Procedure Products Syringe | 2019-10-10 10CC PALM PAD CONTROL SYRINGE, Yellow Plunger |