Duns Number:007941230
Device Description: Stockinette Orthopedic Impervious Moisture-Repellent Barrier Synthetic 6 X 30 Inch Sterile Stockinette Orthopedic Impervious Moisture-Repellent Barrier Synthetic 6 X 30 Inch Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
STK6630
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
KKX
Product Code Name
Drape, surgical
Public Device Record Key
a095e6c9-e517-4f90-81ea-f0421e7a0d25
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50885632126770
Quantity per Package
18
Contains DI Package
10885632126772
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |