Duns Number:002418234
Device Description: OR Utility Drape with Adhesive Strip
Catalog Number
680
Brand Name
Busse Hospital Disposables
Version/Model Number
680
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
K093909,K093909
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
88e17c84-d6e4-463f-af66-34c417ca2394
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 02, 2016
Package DI Number
10849233013909
Quantity per Package
50
Contains DI Package
00849233013902
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 |