Duns Number:007941230
Device Description: Towel Operating Room Pre-Washed De-Linted Cotton Blue 16 X 24 Inch Disposable Bulk Not Mad Towel Operating Room Pre-Washed De-Linted Cotton Blue 16 X 24 Inch Disposable Bulk Not Made With Natural Rubber Latex Non-Sterile MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
ORT400B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K001858,K001858
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
0c35b301-f233-429e-b0b4-ed61deb21e31
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632101760
Quantity per Package
400
Contains DI Package
10885632101762
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |