DEVICE: CIV-Clear™ Transducer Cover (10841436120316)
Device Identifier (DI) Information
CIV-Clear™ Transducer Cover
610-2366
In Commercial Distribution
610-2366, 610-2366-5
CIVCO MEDICAL INSTRUMENTS CO., INC.
610-2366
In Commercial Distribution
610-2366, 610-2366-5
CIVCO MEDICAL INSTRUMENTS CO., INC.
Sterile (14x244cm) telescopically-folded cover
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44714 | Intraoperative ultrasound imaging transducer cover |
A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ITX | Transducer, ultrasonic, diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K211270 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Away from Sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
673c14e1-0f07-4201-b807-026df406f36c
October 28, 2022
2
November 20, 2021
October 28, 2022
2
November 20, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00841436120319 | 24 | 10841436120316 | In Commercial Distribution | ||
00841436122962 | 5 | 00841436120319 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(319)248-6502
regulatory@civco.com
regulatory@civco.com