Duns Number:080246656
Device Description: Solofit Critical Zone AAMI IV Gown, XXXL, Extra Long
Catalog Number
SF-4XXXL-EL
Brand Name
SoloFit
Version/Model Number
SF-4XXXL-EL
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
6014bbe4-0cc2-4a0f-b4a3-a095166cb95b
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
June 03, 2019
Package DI Number
00854150007255
Quantity per Package
25
Contains DI Package
00854150007248
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |