| Primary Device ID | 00616784492834 |
| NIH Device Record Key | bfa53f2c-9c1b-465b-b33f-27f4a5bcf20f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urethral Intermittent Catheter Tray |
| Version Model Number | 4928 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 20 |
| 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 | false |
| Expiration Date | false |
| 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 | 00616784492827 [Unit of Use] |
| GS1 | 00616784492834 [Primary] |
| OHR | Catheter Care Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-11-22 |
| 00810180843331 - Durma+ DynaRule Disposable Paper Rulers | 2026-04-01 |
| 00810180845106 - Cotton Tipped Wood Applicators, Sterile | 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 1 per pouch |
| 00810180845113 - Cotton Tipped Wood Applicators, Sterile | 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 2 per Pouch |
| 00810180840712 - CurPro Dermal Curettes,2 mm | 2026-03-27 Sterile-R |
| 00840117347892 - Medi-Cut Safety Scalpel | 2026-03-27 Medi-Cut Safety Scalpel, Sterile, # 15 |
| 00810180844901 - Disposable Prep Razors | 2026-03-25 Disposable Prep Razors |
| 00810180844918 - Medicine Cups 1oz | 2026-03-25 |
| 00810180844925 - LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal | 2026-03-25 Sterile-EO |