Quik-Clip™ Needle Guide UA0028
GUDID 00841436110259
Sterile needle guide (barrel inserts only) for use with BK Medical 8570, 8584, 8664 and 8812 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
Nonimplantable needle guide, single-use| Primary Device ID | 00841436110259 |
| NIH Device Record Key | 932ecb0a-29e5-44d0-a8c8-f640b9947952 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quik-Clip™ Needle Guide |
| Version Model Number | UA0028 |
| Catalog Number | UA0028 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Device Dimensions
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
| Length | 4.8 Inch |
| Width | 1.8 Inch |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436110259 [Package] Contains: 10841436110256 Package: [20 Units] In Commercial Distribution |
| GS1 | 10841436110256 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093713
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
[00841436110259]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [Quik-Clip™ Needle Guide]
| 00841436110259 | Sterile needle guide (barrel inserts only) for use with BK Medical 8570, 8584, 8664 and 8812 tra |
| 00841436104838 | Sterile needle guide with (14 x 61cm) flat-folded CIV-Flex™ cover for use with Siemens 4V2, V4 |
| 00841436104807 | Sterile needle guide with (5 x 30cm) latex cover for use with Siemens 4V2, V4, V2, L5, L7, C5, C |
Trademark Results [Quik-Clip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUIK-CLIP 85051131 not registered Dead/Abandoned |
Wilkinson, William T. 2010-05-31 |
 QUIK-CLIP 74341277 1785444 Dead/Cancelled |
Rocket Electric Co., LTD., L.A. 1992-12-21 |
 QUIK-CLIP 72267008 0878773 Dead/Expired |
BRUNSWICK CORPORATION 1967-03-17 |
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