Duns Number:008124539
Device Description: Lab Coat without Pockets, Blue, Large
Catalog Number
-
Brand Name
Lab Coat
Version/Model Number
1994
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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
d7930d30-f83a-4bb6-bac6-2cdcbc655918
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784199436
Quantity per Package
3
Contains DI Package
00616784199429
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |