Duns Number:102422578
Device Description: Single use 2-piece protective suit. Extra, extra, extra, extra, extra, extra large size.
Catalog Number
-
Brand Name
Aegis Personal Protective Suit
Version/Model Number
005-00082
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
2d9b6aa8-9d49-45dd-b11f-4e6b312c7b76
Public Version Date
May 12, 2020
Public Version Number
1
DI Record Publish Date
May 04, 2020
Package DI Number
00872320005559
Quantity per Package
3
Contains DI Package
00872320005528
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |