Duns Number:007941230
Device Description: Gown Isolation Isolation AAMI Level 3 SMS Full Back Overhead Thumbloop With Elastic Cuff T Gown Isolation Isolation AAMI Level 3 SMS Full Back Overhead Thumbloop With Elastic Cuff Tie Waist Yellow Universal Not Made With Natural Rubber Latex Medichoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
55583
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
FYC
Product Code Name
GOWN, ISOLATION, SURGICAL
Public Device Record Key
29cd95b6-7134-486d-8fab-39e5866da073
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 14, 2016
Package DI Number
50885632138216
Quantity per Package
10
Contains DI Package
30885632138212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |