Duns Number:001292192
Device Description: TRAY EPID SSTT17G3.5 LOR5
Catalog Number
406030
Brand Name
N/A
Version/Model Number
406030
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
cad0ee4e-8d75-4bd5-8d53-3d0822be1479
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
50382904060300
Quantity per Package
10
Contains DI Package
00382904060305
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |