| Specifications | Medical Device Reporting Annual User Facility Report FORM FDA 3419 PSC Graphics |
| Business section |

| Specifications | Medical Device Reporting Annual User Facility Report FORM FDA 3419 PSC Graphics |
| Business section |

| Specifications | Medical Device Reporting Annual User Facility Report FORM FDA 3419 PSC Graphics |
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| Content | MEDICAL DEVICE REPORTING ANNUAL USER FACILITY REPORT (Continue on a separate sheet, if necessary) PART 2 - SUMMARY OF EVENT FORM FDA 3419 (9/10)PAGE 2 1. USER FACILITY EVENT REPORT NUMBER PART 2 INSTRUCTIONS 4. DEVICE INFORMATION a. Name 3. MANUFACTURER INFORMATION a. Brand Name If photocopies of previously submitted FDA Form 3500A (MedWatch) are not provided for each MDR reportable event, complete one copy of the following for each MDR report submitted to FDA and/or the manufacturer during the calendar year covered by this Annual Report. 2. WHERE WAS REPORT SUBMITTED? (Check all that apply) b. Street Address b. Common Name d. Serial Number c. Model Number c. City f. Country/Postal Code (if not U.S.) d. Statee. ZIP Code f. Catalog Number (Year)(Sequence No.) e. Lot Number FDAManufacturerDistributorOther - (HCFA or FDA Provided No.) 5. BRIEF DESCRIPTION OF EVENT |
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| Following Datasheets | UCM080814_1 (2 pages) UCM080839_1 (3 pages) UCM080858_1 (3 pages) UCM080872_1 (1 pages) ucm080879-1_1 (2 pages) UCM081561_1 (84 pages) UCM081575_1 (32 pages) UCM081600 (76 pages) UCM081603_1 (17 pages) UCM081667_1 (2 pages) |
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