Duns Number:130341956
Device Description: The Winged Guide Accessory may be referred to as the winged guide or guide and is for use The Winged Guide Accessory may be referred to as the winged guide or guide and is for use with the Caldera Medical Inside-Out introducers only.
Catalog Number
CAL-WI
Brand Name
Winged Guide Accessory
Version/Model Number
CAL-WI
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
Yes
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
K172614
Product Code
PWJ
Product Code Name
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Public Device Record Key
9d302e58-cfe6-4421-84f0-2e95051629f4
Public Version Date
July 19, 2022
Public Version Number
3
DI Record Publish Date
September 30, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |