HELITENE® ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM 1692-ZL

GUDID 10381780000228

ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM

Integra Lifesciences Corporation

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

• Primary Device ID: 10381780000228
• NIH Device Record Key: d8471f71-805b-464d-80a7-2db79cbf44dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELITENE® ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM
• Version Model Number: 1692-ZL
• Catalog Number: 1692-ZL
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• 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: false
• 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

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
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• 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
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• 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	00381780000221 [Primary]
GS1	10381780000228 [Package]; Contains: 00381780000221; Package: Box [5 Units]; In Commercial Distribution
HIBCC	M2691692ZL0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850010
• 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: 2018-07-06
• Device Publish Date: 2014-09-11

On-Brand Devices [HELITENE® ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM]

• 10381780000228: ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM
• 10381780000211: ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 1GRAM