Duns Number:801895244
Device Description: Guardian VAGINAL RETRACTOR™ Use for Vaginal Inspection and Repair of Episiotomy and Vagina Guardian VAGINAL RETRACTOR™ Use for Vaginal Inspection and Repair of Episiotomy and Vaginal Laceration
Catalog Number
-
Brand Name
Guardian VAGINAL RETRACTOR™
Version/Model Number
64-330
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
-
Product Code
KOH
Product Code Name
Instrument, Manual, General Obstetric-Gynecologic
Public Device Record Key
829529e0-092f-401a-90e8-0d0ad2e59125
Public Version Date
December 27, 2018
Public Version Number
1
DI Record Publish Date
November 26, 2018
Package DI Number
20888937013188
Quantity per Package
6
Contains DI Package
00888937013184
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |