Duns Number:002418234
Device Description: Ophathalmic Drape w/ 2 1/2" Fenestration & Adhesive Patch, 15" x 15"
Catalog Number
685
Brand Name
Busse Hospital Disposables
Version/Model Number
685
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
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
74d09387-d3ba-4e36-a7eb-c27d5087d693
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 02, 2016
Package DI Number
30849233013408
Quantity per Package
10
Contains DI Package
00849233013407
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 298 |