Vitagel 2113-0003

GUDID 30808232000819

Laparoscopic Extended Applicator

Stryker Orthobiologics

Haematological concentrate applicator Haematological concentrate applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator Haematological concentrate/haemostatic agent applicator

• Primary Device ID: 30808232000819
• NIH Device Record Key: 0fe06ff7-2f78-4edc-82c2-c46d1674cac1
• Commercial Distribution Discontinuation: 2018-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vitagel
• Version Model Number: 2113-0003
• Catalog Number: 2113-0003
• Company DUNS: 849227939
• Company Name: Stryker Orthobiologics
• 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: 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(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Dry and Ambient

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808232000818 [Primary]
GS1	30808232000819 [Package]; Contains: 00808232000818; Package: pack [10 Units]; Discontinued: 2018-06-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050044

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: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2014-09-24

On-Brand Devices [Vitagel]

• 30808232000819: Laparoscopic Extended Applicator
• 30808232000802: Malleable Extended Applicator