Variety Pack H2O-013
GUDID 00841436120449
Envision Variety Pack with H2O-001, H2O-003, H2O-004, and H2O-005
CIVCO MEDICAL INSTRUMENTS CO., INC.
Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover| Primary Device ID | 00841436120449 |
| NIH Device Record Key | e6738834-cae4-4606-9f43-5eed16243fa1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Variety Pack |
| Version Model Number | H2O-013 |
| Catalog Number | H2O-013 |
| 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 | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436120449 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190802
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
[00841436120449]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-01 |
| Device Publish Date | 2021-01-22 |
Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.
| 20841436122584 - Needle Guide Bracket | 2024-02-16 Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta L18X transducers |
| 20841436122614 - Needle Guide Bracket | 2024-02-16 Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta MC10-3 transducers |
| 20841436123161 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Esaote C 1-8E and CX 1-8A transducers |
| 20841436123314 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung CMV1-10 transducers |
| 20841436124335 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Canon Medical Systems 12L4 transducers |
| 20841436124939 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung LA2-16S transducers |
| 20841436124960 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung L3-22 transducers |
| 00841436120913 - Transducer Cover | 2024-02-16 Non-sterile (14 x 147cm) telescopically- folded CIV-Flex cover with Envision |
Trademark Results [Variety Pack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VARIETY PACK 97437250 not registered Live/Pending |
POGALA LLC 2022-06-01 |
 VARIETY PACK 78725234 3455340 Dead/Cancelled |
Kellogg North America Company 2005-10-03 |
 VARIETY PACK 78152146 not registered Dead/Abandoned |
Teisseire France 2002-08-08 |
 VARIETY PACK 74403884 not registered Dead/Abandoned |
Recot, Inc. 1993-06-18 |
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