Duns Number:046355210
Device Description: Reusable Titanium BP Frcps, 2 3/4" WL, Mark "DUAL-0.5S" on Cup, Add Dual Irr. 0.032 Irr. T Reusable Titanium BP Frcps, 2 3/4" WL, Mark "DUAL-0.5S" on Cup, Add Dual Irr. 0.032 Irr. Tube Surface Mounted on Handle but Buried in WL, 2 Stops Grooved to Interlock with an Irr. Tube When Closed. (Special)
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
15-5402AUS
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"
Yes
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
K844823
Product Code
KNA
Product Code Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Public Device Record Key
49faeae3-2557-48b0-853e-789e08ee4543
Public Version Date
February 05, 2020
Public Version Number
1
DI Record Publish Date
January 28, 2020
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 | 60 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1505 |
| U | Unclassified | 2 |