Duns Number:618054084
Device Description: PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for endocervica PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for endocervical application: 0.5 mg PGE2 per 3.0 g (2.5 mL) in syringe. In addition, each package contains two shielded catheters (10 mm and 20 mm tip) enclosed in sterile envelopes. The contents are not guaranteed sterile if envelopes are not intact.
Catalog Number
-
Brand Name
Prepidil® Gel, dinoprostone cervical gel
Version/Model Number
NDC 0009-3359-01
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
-
Product Code Name
-
Public Device Record Key
67717963-32ca-4a4c-8315-9b7cd87a0f69
Public Version Date
December 17, 2020
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
00300093359024
Quantity per Package
5
Contains DI Package
00300093359017
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |
| 3 | A medical device with high risk that requires premarket approval | 11 |