Primary Device ID | 00841436120395 |
NIH Device Record Key | 3698e97a-8b05-4cc4-8bfb-7753d87077c1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Needle Guide Starter Kit |
Version Model Number | P27064-01 |
Catalog Number | P27064-01 |
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 |
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 | 00841436120395 [Primary] |
GS1 | 20841436120382 [Direct Marking] |
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 | 2021-01-28 |
Device Publish Date | 2021-01-20 |
00841436113731 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
00841436110921 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 147c |
00841436110150 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CI |
00841436110143 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CI |
00841436110136 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CI |
00841436110129 | Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 14 |
00841436110112 | Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 14 |
00841436110105 | Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), |
00841436110099 | Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C |
00841436110082 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) C |
00841436110044 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guide (5), (14 x 147cm) CI |
00841436109963 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) C |
00841436109956 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) C |
00841436109925 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
00841436109901 | Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) |
00841436107198 | Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P |
00841436107181 | Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P |
00841436107051 | Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P |
00841436107037 | Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 14 |
00841436107020 | Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147 |
00841436107013 | Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) with |
00841436107006 | Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P |
00841436106993 | Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P |
00841436106986 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436106979 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436106962 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436106955 | Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P |
00841436181198 | Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), |
00841436107143 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120838 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides(2), Infiniti |
00841436120821 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120814 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120807 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides(2), Infiniti |
00841436120791 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120784 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120777 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120760 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120418 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120395 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436120371 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436118620 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436110860 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
00841436114288 | Reusable non-sterile single-angle bracket with AccuSITE™ needle guides (5) and (14 × 147cm) C |
00841436121637 | Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit |
20841436122713 | Reusable non-sterile single-angle bracket with AccuSITE™ needle guides (5) and (14 × 147cm) C |