Duns Number:040729840
Device Description: CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK STRAIGHT TUNGSTEN CARBIDE INSERT FLAT HANDLE
Catalog Number
15-1901
Brand Name
CASTROVIEJO NEEDLE HOLDER
Version/Model Number
15-1901
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
HCF
Product Code Name
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Public Device Record Key
0d7deb50-63b9-4637-aa88-2b548234d871
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
September 20, 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 |