| Primary Device ID | 00841436120883 | 
| NIH Device Record Key | 7c789369-ee28-4b58-a197-cfaf5052af2b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Drape | 
| Version Model Number | 610-2382 | 
| Catalog Number | 610-2382 | 
| Company DUNS | 134614411 | 
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | |
| Phone | +1(319)248-6502 | 
| regulatory@civco.com | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Width | 32.4 Centimeter | 
| Length | 27.9 Centimeter | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841436120883 [Package] Contains: 10841436120880 Package: [24 Units] In Commercial Distribution | 
| GS1 | 10841436120880 [Primary] | 
| ITX | Transducer, ultrasonic, diagnostic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-01-29 | 
| Device Publish Date | 2021-01-21 | 
| 00841436120883 | Non-sterile (32.4x27.9cm) polyethlene drape | 
| 00841436120876 | Non-sterile (50.8x71.1cm) polyethlene drape | 
| 00841436102766 | Sterile (32.4 x 27.9cm) polyethylene drape | 
| 00841436101820 | Sterile (15.2 x 25.4cm) polyethylene cover | 
| 00841436101790 | Sterile polyethylene drape (50.8 x 71.1cm) |