Duns Number:023055619
Device Description: SCANLAN® Brigid™ Mini Foerster Clamp, curved 10cm working length
Catalog Number
9209-220
Brand Name
SCANLAN® Thoracoscopic
Version/Model Number
9209-220
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
-
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
K945474
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
5277bc3c-9ebc-4bb6-82fe-6382f2c56001
Public Version Date
May 06, 2022
Public Version Number
1
DI Record Publish Date
April 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |