Duns Number:063519193
Device Description: Microscope Drape for Leica M844 BIOM Compatible46” x 60” Drawstring
Catalog Number
-
Brand Name
Drapetech
Version/Model Number
28327
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EPT
Product Code Name
Microscope, Surgical
Public Device Record Key
635a8650-6a25-4108-8840-108d6f0b66ef
Public Version Date
February 06, 2020
Public Version Number
5
DI Record Publish Date
December 08, 2016
Package DI Number
00618125175703
Quantity per Package
10
Contains DI Package
01618125175702
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |