Prepidil® Gel, dinoprostone cervical gel

GUDID 00300093359024

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.

PHARMACIA & UPJOHN COMPANY LLC

Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter Cervical dilatation catheter

• Primary Device ID: 00300093359024
• NIH Device Record Key: 67717963-32ca-4a4c-8315-9b7cd87a0f69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prepidil® Gel, dinoprostone cervical gel
• Version Model Number: NDC 0009-3359-01
• Company DUNS: 618054084
• Company Name: PHARMACIA & UPJOHN COMPANY LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arrenon@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300093359017 [Primary]
GS1	00300093359024 [Package]; Contains: 00300093359017; Package: [5 Units]; In Commercial Distribution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

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