Duns Number:014464314
Device Description: Microscope Drape, Leica 137x381cm – 54” x 150”
Catalog Number
EP5513
Brand Name
Exact Medical Manufacturing
Version/Model Number
EP5513
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMW
Product Code Name
Drape, Microscope, Ophthalmic
Public Device Record Key
53dc9814-5461-4bae-bcac-98ea2a8584a5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 24, 2017
Package DI Number
00852205007946
Quantity per Package
1
Contains DI Package
00852205007939
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 |