| Primary Device ID | B504OM10590U0 |
| NIH Device Record Key | edc9407a-b18c-41d4-9c2b-b37c48a61c68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Parcus Medical |
| Version Model Number | 10590U |
| 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 | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B504OM10590U0 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-30 |
| Device Publish Date | 2024-05-22 |
| B504OMPDS2NL300 - Nakanishi | 2026-02-17 |
| B504OM13090119XG10 - Zimmer | 2025-12-03 |
| B504OM19100119XG10 - Zimmer | 2025-12-03 |
| B504OM20090119XC10 - Zimmer | 2025-12-03 |
| B504OM20100119XC10 - Zimmer | 2025-12-03 |
| B504OM20100119XCW0 - Zimmer | 2025-12-03 |
| B504OM21090119XGW0 - Zimmer | 2025-12-03 |
| B504OM17090127YGS0 - Zimmer | 2025-09-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PARCUS MEDICAL 77495391 3775476 Live/Registered |
Parcus Medical LLC 2008-06-10 |