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| 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.
| 20841436122881 - Verza Guidance System | 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Esaote LMX3-16 transduce |
| 20841436125356 - Verza Guidance System | 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Philips eL 10-2 transduc |
| 20841436125516 - Verza Guidance System | 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare L8-18t tra |
| 20841436125523 - Needle Guidance System | 2026-01-08 Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) |
| 20841436125530 - Needle Guidance System | 2026-01-08 Reusable non-sterile bracket with AccuSITE™ needle guides (5), and (14x147cm) CIV-Flex™ covers (5) for use with GE Healthca |
| 20841436126261 - Verza Guidance System | 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Samsung CM2-11 transduce |
| 20841436126339 - Verza Guidance System | 2026-01-08 Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with Samsung CM1-8 transducer |
| 20841436126346 - Tracking Bracket Starter Kit | 2026-01-08 Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CM1-8 and CM2-11 tr |
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 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.