Duns Number:063519193
Device Description: Polyethylene, Over-the-Head, Protective Gown, ANSI/AAMI PB70 Level 2 Protection, Open back Polyethylene, Over-the-Head, Protective Gown, ANSI/AAMI PB70 Level 2 Protection, Open back - Back of gown is not protective, Universal Size, Blue, Polyethylene
Catalog Number
8576A
Brand Name
TIDI
Version/Model Number
8576A
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)
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
cec13919-15b7-47b0-b85a-18901bdc3ac3
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 07, 2022
Package DI Number
10618125189349
Quantity per Package
75
Contains DI Package
00618125189342
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |