Gelfoam

GUDID 00300090315085

Absorbable Hemostatic Sponge, Collagen Based

PHARMACIA & UPJOHN COMPANY LLC

Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial Collagen haemostatic agent, non-antimicrobial

• Primary Device ID: 00300090315085
• NIH Device Record Key: 87463f38-6e9c-40ee-8ad7-f50a5881967c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gelfoam
• Version Model Number: Size 12-7
• Company DUNS: 618054084
• Company Name: PHARMACIA & UPJOHN COMPANY LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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: 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

Device Dimensions

• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter
• Length: 60 Millimeter
• Width: 20 Millimeter
• Height: 7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *See USP Controlled Room Temperature
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300090315085 [Package]; Contains: 10300090315082; Package: Carton [12 Units]; In Commercial Distribution
GS1	10300090315082 [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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-12-17
• Device Publish Date: 2014-09-01

On-Brand Devices [Gelfoam]

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• 00300090353018: Absorbable Hemostatic Sponge, Collagen Based
• 00300090349035: Absorbable Hemostatic Sponge, Collagen Based
• 00300090342012: Absorbable Hemostatic Sponge, Collagen Based
• 00300090323011: Absorbable Hemostatic Sponge, Collagen Based
• 00300090315085: Absorbable Hemostatic Sponge, Collagen Based