NeoGuard™ 610-1127
GUDID 00841436102179
Non-sterile (2.0 x 30cm) cover
CIVCO MEDICAL INSTRUMENTS CO., INC.
Intraoperative ultrasound imaging transducer cover Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic Body-orifice ultrasound imaging transducer cover, basic| Primary Device ID | 00841436102179 |
| NIH Device Record Key | d68c3178-0c7f-476d-9a91-3d9e351a572c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoGuard™ |
| Version Model Number | 610-1127 |
| Catalog Number | 610-1127 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 24 |
| 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 |
Device Dimensions
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
| Length | 30 Centimeter |
| Width | 2 Centimeter |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436102179 [Primary] |
| GS1 | 80841436102175 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013721
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [NeoGuard™]
| 00841436110303 | Sterile (2.6 x 30cm) cover for use with BK Medical 2050, 2052 and 20R3 transducers |
| 00841436107273 | Non-sterile (2.6 x 30cm) cover |
| 00841436104210 | Non-sterile (4 x 30cm) cover |
| 00841436104203 | Non-sterile (2.6 x 30cm) cover |
| 00841436104197 | Non-sterile (2.6 x 30cm) cover |
| 00841436102179 | Non-sterile (2.0 x 30cm) cover |
| 00841436101813 | Non-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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