GEL-FLOW KIT

GUDID 00300092250018

GEL-FLOW NT Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI, 5,000 International Units Syringe Spray Kit

PFIZER INC.

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• Primary Device ID: 00300092250018
• NIH Device Record Key: 083964e9-7d44-41de-9b57-ce7d2d9c9835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEL-FLOW KIT
• Version Model Number: 6 mL
• Company DUNS: 829076566
• Company Name: PFIZER INC.
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@pfizer.com
• Phone: +1(484)865-6166
• Email: karena.arroyo@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
• 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 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300092250018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N18286

FDA Product Code

• LMF: Agent, absorbable hemostatic, collagen based

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: 2018-09-17
• Device Publish Date: 2018-08-17

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