Duns Number:007941230
Device Description: Gown Isolation Aami Level 3 Sms Full Back Overhead Thumbloop With Elastic Cuff Tie Waist B Gown Isolation Aami Level 3 Sms Full Back Overhead Thumbloop With Elastic Cuff Tie Waist Blue Universal Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
55883
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
7e930864-28d8-4735-9f9b-a8e4dec73c92
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 17, 2016
Package DI Number
50885632138230
Quantity per Package
10
Contains DI Package
30885632138236
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 |