Home GUDID 00300093359024 Prepidil® Gel, dinoprostone cervical gel
Primary DI 00300093359024
Brand Prepidil® Gel, dinoprostone cervical gel
Company PHARMACIA & UPJOHN COMPANY LLC
Model NDC 0009-3359-01
Device description 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.
Published 2020-09-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00300093359024 Package GS1 5 In Commercial Distribution 00300093359017 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00300093359024 00300093359024 300093359024 0300093359024 00300093359017 00300093359017 300093359017 0300093359017
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 618054084 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 
pfizer.com