Duns Number:081330555
Device Description: DISPOSABLE LAB COAT - MEDIUM 10/BAG (LAVENDER)
Catalog Number
SG-9014
Brand Name
Defend
Version/Model Number
SG-9014
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FME
Product Code Name
Gown, Examination
Public Device Record Key
4ee562da-865d-4f93-bac7-33a5bbc94e56
Public Version Date
September 27, 2022
Public Version Number
4
DI Record Publish Date
March 23, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 61 |
2 | A medical device with a moderate to high risk that requires special controls. | 103 |