ORAFOAM ORAFOAM-PKG-18

GUDID 10381780508656

ORAFOAM Absorbable Collagen Hemostatic Sponge 1/2" x 1"

Integra Lifesciences Corporation

Collagen haemostatic agent, non-antimicrobial

• Primary Device ID: 10381780508656
• NIH Device Record Key: ffa76314-2151-4a89-8c27-bf23a181b7cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORAFOAM
• Version Model Number: ORAFOAM-PKG-18
• Catalog Number: ORAFOAM-PKG-18
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 18
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780508659 [Unit of Use]
GS1	10381780508656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850010

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: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2019-02-04

Devices Manufactured by Integra Lifesciences Corporation

• 10381780268536 - Omni-Tract®: 2024-07-18 Omni-Tract® Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
• 10381780269106 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 3in (3.8cm x 7.6cm)
• 10381780269113 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 4in (3.8cm x 10.2cm)
• 10381780538134 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 5in (3.8cm x 12.7cm)
• 10381780538158 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, .75in x 2in (1.9cm x 5.1cm)
• 10381780538165 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Retractor, 1in x 3in (2.5cm x 7.6cm) Mini
• 10381780538172 - Omni-Tract®: 2024-07-18 Omni-Tract® Medial Retractor, 1.5in x 3.5in (3.8cm x 8.9cm)
• 10381780538189 - Omni-Tract®: 2024-07-18 Omni-Tract® Meyerding Retractor, Blunt, 1in x 3in (2.5cm x 7.6cm)