Duns Number:149818952
Device Description: Epidural Needle, 14 gauge, 4" (10cm)
Catalog Number
1114
Brand Name
NA
Version/Model Number
1114
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
K050922,K050922
Product Code
GZB
Product Code Name
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Public Device Record Key
ef0d72f2-b036-4a08-b5c0-57fd6fa9f0d6
Public Version Date
February 10, 2022
Public Version Number
4
DI Record Publish Date
April 16, 2015
Package DI Number
15414734400128
Quantity per Package
5
Contains DI Package
05414734400121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |