DEVICE: Stradis Medical, LLC (M752RWMDCTSOR0)
Device Identifier (DI) Information
Stradis Medical, LLC
RWM-DCT-SOR
Not in Commercial Distribution
STRADIS MEDICAL, LLC
RWM-DCT-SOR
Not in Commercial Distribution
STRADIS MEDICAL, LLC
Dressing Change Tray
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? |
---|---|---|---|---|
34059 | Wound dressing kit, medicated |
A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e59ac2e0-57b0-4c53-8bc7-9ff79c48f333
January 26, 2023
3
October 08, 2018
January 26, 2023
3
October 08, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M752RWMDCTSOR5 | 40 | M752RWMDCTSOR0 | 2023-01-25 | Not in Commercial Distribution | outer box |
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
[?]
1-800-424-8520
cs@stradishealthcare.com
cs@stradishealthcare.com