| Primary Device ID | B504GS3350L4G0 |
| NIH Device Record Key | f0a6f4e7-005c-4150-9790-c5be4169a156 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cooper Medical |
| Version Model Number | 3350L-4G |
| Company DUNS | 016889401 |
| Company Name | Provision |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com | |
| Phone | 541-508-7520 |
| customersupport@provisiondrs.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B504GS3350L4G0 [Primary] |
| KDC | Instrument, Surgical, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-08 |
| Device Publish Date | 2024-09-30 |
| B504OM17090127YGS0 - Zimmer | 2025-09-11 |
| B504OM0145080 - Smith and Nephew | 2025-06-27 |
| B504OM254400111D0 - DePuy Mitek | 2025-06-18 |
| B504OM254400111P0 - DePuy Mitek | 2025-06-18 |
| B504AS35ULTSTZZ0 - Conmed Linvatec | 2025-05-05 |
| B504AS42FRRRAZZ0 - Conmed Linvatec | 2025-05-05 |
| B504AS9247A0 - Conmed Linvatec | 2025-05-05 |
| B504AS9297A0 - Conmed Linvatec | 2025-05-05 |