| Primary Device ID | B16097211 |
| NIH Device Record Key | 567a074f-c102-40a3-98a6-e0ab7753fcb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procedure Products Needles |
| Version Model Number | 9721 |
| 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 | B16097211 [Primary] |
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-12 |
| B16097211 | 18 Gauge Filter Pack |
| B1605518291 | 2 PART, 7CM, SELDINGER, KSDN PLATE |
| B1603293552 | 19ga, 1-wall needle |
| B160311827P1 | NEEDLE, W/O BASEPLATE 7CM 18g W/ PLUG |
| B1603118151 | NEEDLES, W/O BASEPLATE 3.8CM 18g |
| B1602293572 | 19ga, 7cm, 1-part needle |
| B1602118352 | NEEDLE, BSDN PLATE 1 PART 9 CM 18g |
| B160211827P1 | 18 GA needle, 7cm, BSDN, with Plug |
| B1602018401 | NEEDLE, 2 PART, 10.2cm, 18g, MODIFIED POTTS |
| B1602018221 | Needle, 18ga, 5.7cm, 2-part |