Duns Number:051420107
Device Description: Towel Drapes Sterile 696/605
Catalog Number
-
Brand Name
Moore Medical
Version/Model Number
14170
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
27f12683-bdee-42e3-b9a1-253b0e733665
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
December 09, 2016
Package DI Number
20607415001574
Quantity per Package
50
Contains DI Package
10607415001997
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |