DEVICE: MICROTEK (00748426047284)
Device Identifier (DI) Information
MICROTEK
1
In Commercial Distribution
Microtek Medical LLC
1
In Commercial Distribution
Microtek Medical LLC
GENERAL PURPOSE PROBE COVER, 3" X 24", 20-PACK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
44713 | Body-surface ultrasound imaging transducer cover |
A device/material 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 system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KKX | Drape, surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K882724 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store under normal warehouse conditions. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ce48cef6-038a-4b2c-b646-2d2263b840ac
February 05, 2025
7
December 23, 2016
February 05, 2025
7
December 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30748426047285 | 20 | 00748426047284 | In Commercial Distribution | ||
50748426047289 | 1 | 30748426047285 | 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(800)824-3027
customerservicemicrotekmed.com@ecolab.com
customerservicemicrotekmed.com@ecolab.com