Duns Number:014464314
Catalog Number
-
Brand Name
E6566 Foot Switch Cover with adhesive 36x76cm - 14"x30"
Version/Model Number
E6566
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
59ed343a-9d67-4a8b-8ffb-d0afda5b5a38
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 28, 2016
Package DI Number
00852205007311
Quantity per Package
100
Contains DI Package
00852205007304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 489 |