DEVICE: Medichoice (10885632101731)
Device Identifier (DI) Information
Medichoice
ORT04G
In Commercial Distribution
OWENS & MINOR DISTRIBUTION, INC.
ORT04G
In Commercial Distribution
OWENS & MINOR DISTRIBUTION, INC.
MediChoice O.R. Towel, X-Ray Detectable, 16 Inch X 24 Inch, Green (Case Of 80)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 14077 | Surgical towel |
A sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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 [?] |
|---|---|
| K001858 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Keep Dry |
| Special Storage Condition, Specify: |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
0cd59de0-617b-41c6-8ab5-e8177027794d
July 06, 2018
3
August 20, 2016
July 06, 2018
3
August 20, 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 |
|---|---|---|---|---|---|
| 50885632101739 | 20 | 10885632101731 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
60885632101736
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined