Duns Number:119676187
Device Description: The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows thecover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover beingfolded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
Catalog Number
-
Brand Name
eShield Digital Camera Size
Version/Model Number
EC2200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141438,K141438
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
f34ff369-8e32-4b06-b65d-6c51a8fcca7e
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 20, 2016
Package DI Number
M266EC22001
Quantity per Package
25
Contains DI Package
M266EC22000
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |