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| 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 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| 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 |
Devices Manufactured by PHARMACIA & UPJOHN COMPANY LLC
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| 00300090349035 - Gelfoam | 2020-12-17 Absorbable Hemostatic Sponge, Collagen Based |
| 00300090353018 - Gelfoam | 2020-12-17 Absorbable Hemostatic Sponge, Collagen Based |
| 00300090396053 - Gelfoam | 2020-12-17 Absorbable Hemostatic Sponge, Collagen Based |
| 00300090433048 - Gelfoam | 2020-12-17 Absorbable Hemostatic Powder, Collagen Based |
Trademark Results [Prepidil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREPIDIL 73393050 1417143 Live/Registered |
Upjohn Company, The 1982-09-29 |
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