Duns Number:832696038
Device Description: Safe-T PLUS Amniocentesis Tray, 20 G x 3 1/2 Inch Spinal Needle With Centimeter Depth Mark Safe-T PLUS Amniocentesis Tray, 20 G x 3 1/2 Inch Spinal Needle With Centimeter Depth Markings
Catalog Number
4545ASP
Brand Name
Safe-T
Version/Model Number
4545ASP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJT
Product Code Name
Aspiration tray
Public Device Record Key
c6f5a5d7-5d88-4ea8-8126-3df8722c6979
Public Version Date
December 13, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
50885403108158
Quantity per Package
10
Contains DI Package
10885403108150
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |