Duns Number:783912892
Device Description: Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back
Catalog Number
-
Brand Name
Precept®
Version/Model Number
51192
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
a2bb6af9-d889-4bf9-a890-2b32d663de6b
Public Version Date
October 19, 2018
Public Version Number
1
DI Record Publish Date
September 18, 2018
Package DI Number
20814707020773
Quantity per Package
10
Contains DI Package
10814707020776
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |