Duns Number:080361159
Device Description: COVERALL, BLUE, 3XLARGE, OPEN CUFF, OPEN ANKLE, TRADITIONAL COLLAR, ZIPPER FRONT, SBPP, 5E COVERALL, BLUE, 3XLARGE, OPEN CUFF, OPEN ANKLE, TRADITIONAL COLLAR, ZIPPER FRONT, SBPP, 5EA/BG, 10BG/CS
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
GNT210-CV1
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
8cc4c169-4da6-4201-ab6c-5735319e7264
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 02, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |