| Primary Device ID | 00841436105989 |
| NIH Device Record Key | d73dccff-ca39-4d93-a6d9-4e204e2507de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biopsy Starter Kit |
| Version Model Number | 644-082 |
| Catalog Number | 644-082 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | +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 | |
| 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 |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Length | 4.42 Inch |
| Height | 2.43 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436105989 [Primary] |
| GS1 | 20841436115289 [Direct Marking] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-08-22 |
| 00841436111652 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5), (14 × 91.5cm) |
| 00841436111584 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5), (14 × 91.5cm) |
| 00841436111577 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5), (14 × 147cm) C |
| 00841436111225 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
| 00841436110501 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 91.5c |
| 00841436110396 | Reusable non-sterile single-angle bracket with Ultra-Pro 3™ Needle guides (5), (14 x 91.5cm) C |
| 00841436109505 | Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex |
| 00841436109420 | Reusable non-sterile position sensor mount multi-angle bracket with Ultra-Pro II™ Needle guide |
| 00841436109413 | Reusable non-sterile position sensor mount multi-angle bracket with Ultra-Pro II™ Needle guide |
| 00841436109376 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436109307 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436109222 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436109215 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5) (14 x 91.5cm) CI |
| 00841436109192 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436109185 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
| 00841436109178 | Reusable non-sterile bracket with AccuSITE needle guides (5), (14 x 147cm) covers (5) for use wi |
| 00841436109161 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436109154 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436109147 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436109130 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436108980 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108973 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108966 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108928 | Reusable non-sterile multi-angle needle guide with cleaning brushes (5), (8.9 x 91.5cm) CIV-Flex |
| 00841436108911 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (8.9 x 91.5cm) |
| 00841436108812 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guide (5), (14 x 91.5cm) CI |
| 00841436108799 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108782 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108744 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436108737 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108720 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108713 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108706 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108690 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108683 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
| 00841436108652 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436108645 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 20841436117559 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436108065 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (8.9 x 91.5cm) |
| 00841436108058 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
| 00841436108034 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
| 00841436108027 | Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex |
| 00841436107983 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
| 00841436107976 | Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex |
| 00841436107969 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
| 00841436107952 | Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex |
| 00841436107945 | Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex |
| 00841436107938 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436107921 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
| 00841436107907 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |