Duns Number:015272206
Device Description: VATS thoracoscopic dissecting scissors, 15'', 190mm working length, 5.0mm diameter, curved VATS thoracoscopic dissecting scissors, 15'', 190mm working length, 5.0mm diameter, curved 35.0mm blades, blunt tips, ring handle
Catalog Number
80-428
Brand Name
Ambler Surgical
Version/Model Number
VATS thoracoscopic dissecting scissors
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
-
Product Code
LRW
Product Code Name
SCISSORS, GENERAL, SURGICAL
Public Device Record Key
14af2d75-406d-4011-8697-6acf142239c2
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
January 04, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |