Duns Number:015272206
Device Description: DeBakey needle pulling tissue forceps, 9 1/2", delicate, straight, 2x4 teeth, 1.5mm TC tip DeBakey needle pulling tissue forceps, 9 1/2", delicate, straight, 2x4 teeth, 1.5mm TC tips with serrated platform, flat handle
Catalog Number
28-732
Brand Name
Ambler Surgical
Version/Model Number
28-732
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
K092544
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
c3087a56-9e49-4a04-880f-6af2eb7acd38
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2016
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 |