Duns Number:135057938
Device Description: CHESBROUGH® Breast Localization Wire, 19g x 9cm
Catalog Number
460919
Brand Name
CHESBROUGH®
Version/Model Number
460919
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
a6f6f0af-11b3-45b7-9c98-0e0fc11de7c0
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
10801741079969
Quantity per Package
10
Contains DI Package
00801741079962
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 |