Duns Number:008124539
Device Description: Isolation Gown, Poly-Coated Barrier, White, 7XL, Impervious
Catalog Number
-
Brand Name
Isolation Gown
Version/Model Number
2148
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
497e560f-9e1f-4ea9-a86f-822ab8f7dd06
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
Package DI Number
00616784214832
Quantity per Package
10
Contains DI Package
00616784214825
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |