Primary Device ID | 00841436102131 |
NIH Device Record Key | 167ece4d-91a1-425d-87a9-2d967763af3d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AccuSITE Needle Guide |
Version Model Number | 610-1017, 610-1030, 610-1123 |
Catalog Number | 610-1017, 610-1030, 610-1123 |
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 | 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 | +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 |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 Inch |
Width | 3.3 Inch |
Length | 5.5 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841436101646 [Package] Contains: 10841436101643 Package: [24 Units] In Commercial Distribution |
GS1 | 00841436101738 [Package] Contains: 00841436101646 Package: [5 Units] In Commercial Distribution |
GS1 | 00841436102131 [Package] Contains: 00841436101738 Package: [12 Units] In Commercial Distribution |
GS1 | 10841436101643 [Primary] |
ITX | Transducer, ultrasonic, diagnostic |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
[00841436102131]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-10-07 |
Device Publish Date | 2017-08-22 |
00841436102568 | Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co |
00841436102551 | Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co |
00841436102506 | Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co |
00841436102155 | Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover |
00841436101653 | Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover |
00841436102131 | Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover |
00841436101752 | Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover |
00841436101738 | Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover |