| Primary Device ID | 10684995520063 |
| NIH Device Record Key | 0f5f8285-1325-440d-b0a8-9a17aee2a12d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Tubing, Penrose Drain |
| Version Model Number | GR201 |
| Company DUNS | 080524654 |
| Company Name | BENTEC MEDICAL OPCO, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00684995520066 [Primary] |
| GS1 | 10684995520063 [Package] Contains: 00684995520066 Package: [25 Units] In Commercial Distribution |
| GBX | Catheter, Irrigation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
| 10684995520155 | 1 in. x 36 in. Length |
| 10684995520148 | 3/4 in. x 36 in. Length |
| 10684995520131 | 1/2 in. x 36 in. Length |
| 10684995520124 | 1/4 in. x 36 in. Length |
| 10684995520117 | 1 in. x 18 in. Length |
| 10684995520100 | 3/4 in. x 18 in. Length |
| 10684995520094 | 5/8 in. x 18 in. Length |
| 10684995520087 | 1/2 in. x 18 in. Length |
| 10684995520070 | 3/8 in. x 18 in. Length |
| 10684995520063 | 1/4 in. x 18 in. Length |
| 10684995520056 | 1 in. x 12 in. Length |
| 10684995520049 | 3/4 in. x 12 in. Length |
| 10684995520032 | 5/8 in. x 12 in. Length |
| 10684995520025 | 1/2 in. x 12 in. Length |
| 10684995520018 | 3/8 in. x 12 in. Length |
| 10684995520001 | 1/4 in. x 12 in. Length |