Duns Number:040729840
Device Description: TITANIUM DEBAKEY NEONATAL CLAMP 90 DEGREE SMALL DOUBLE ANGLED JAW RIGHT ANGLED SHANK 4.75 TITANIUM DEBAKEY NEONATAL CLAMP 90 DEGREE SMALL DOUBLE ANGLED JAW RIGHT ANGLED SHANK 4.75 INCHES
Catalog Number
-
Brand Name
TITANIUM DEBAKEY NEONATAL CLAMP
Version/Model Number
2605-159D
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
5118b21d-f0b3-48ee-b13b-5ab8d2340141
Public Version Date
February 18, 2021
Public Version Number
4
DI Record Publish Date
August 24, 2018
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |