Duns Number:135057938
Device Description: BARD® Needle Guide for use with the Lorad™ StereoGuide™ System
Catalog Number
GL1416
Brand Name
BARD®
Version/Model Number
GL1416
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
-
Product Code
GDF
Product Code Name
GUIDE, NEEDLE, SURGICAL
Public Device Record Key
88f91863-e83b-4d5c-bf43-c065aa08b32c
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
10801741085212
Quantity per Package
25
Contains DI Package
00801741085215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |