Duns Number:012430880
Device Description: HS Sterile Drape, Non-Fen.,18x26" ST
Catalog Number
9004686
Brand Name
Henry Schein/DE
Version/Model Number
9004686
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"
-
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
8de36fc4-a769-4afb-92fd-7da7e1fa070b
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10304040005979
Quantity per Package
6
Contains DI Package
00304040005972
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |