NeoGuard™ Transducer Cover 610-1038
GUDID 00841436101806
Sterile (2.6 x 30cm) cover
CIVCO MEDICAL INSTRUMENTS CO., INC.
Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic, sterile Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic| Primary Device ID | 00841436101806 |
| NIH Device Record Key | 3cb16ccb-2f59-482f-aa5a-6ba95d1878ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoGuard™ Transducer Cover |
| Version Model Number | 610-1038 |
| Catalog Number | 610-1038 |
| 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 |
Device Dimensions
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
Operating and Storage Conditions
| 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 | 00841436101806 [Package] Contains: 10841436101803 Package: [50 Units] In Commercial Distribution |
| GS1 | 10841436101803 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013721
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
[00841436101806]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [NeoGuard™ Transducer Cover]
| 00841436111720 | Non-sterile (2.6 x 30cm) cover |
| 00841436111713 | Non-sterile (2.6 x 30cm) cover |
| 00841436104265 | Sterile (4 x 30cm) cover |
| 00841436104258 | Sterile (2.6 x 30cm) cover |
| 00841436102162 | Sterile (2.0 x 30cm) cover |
| 00841436101806 | Sterile (2.6 x 30cm) cover |
Trademark Results [NeoGuard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEOGUARD 98394754 not registered Live/Pending |
Neology, Inc. 2024-02-06 |
 NEOGUARD 76371898 2767803 Live/Registered |
CIVCO Medical Instruments, Inc. 2002-02-19 |
 NEOGUARD 76364837 2618252 Live/Registered |
QUEST GROUP, LLC 2002-01-28 |
 NEOGUARD 76312277 2843494 Dead/Cancelled |
Intervet, Inc. 2001-09-14 |
 NEOGUARD 75350156 not registered Dead/Abandoned |
Intervet, Inc. 1997-09-02 |
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