Duns Number:191705904
Device Description: COVERALL, E/W&A, COLLAR;WHITE, XL
Catalog Number
68-601W-X
Brand Name
A Plus
Version/Model Number
1
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)
-
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
f6f80fb6-0a73-4688-a60e-86f7df173c14
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 2020
Package DI Number
80683534080043
Quantity per Package
25
Contains DI Package
00683534080047
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 | 83 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 29 |