Duns Number:002418234
Device Description: Pain Management Drape 24" x 30" w/ 4"x 8" Fen and Adh strip
Catalog Number
690
Brand Name
Busse Hospital Disposables
Version/Model Number
690
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
K082297,K082297
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
522d71dd-5dbd-4aa3-b84e-eb03d85dc21e
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 02, 2016
Package DI Number
10849233013442
Quantity per Package
100
Contains DI Package
00849233013445
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 |