Vitagel 2113-0211

GUDID 30808232001380

RT3 REACH9 Malleable Applicator

Stryker Corporation

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: 30808232001380
• NIH Device Record Key: 9e9d5b54-50ea-4b42-b24e-e5fcb38ad60c
• Commercial Distribution Discontinuation: 2018-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vitagel
• Version Model Number: 2113-0211
• Catalog Number: 2113-0211
• Company DUNS: 149183167
• Company Name: Stryker 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: 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: true
• 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

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808232001389 [Primary]
GS1	30808232001380 [Package]; Contains: 00808232001389; Package: pack [5 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]

• 30808232001397: RT3 REACH38 Laparoscopic Applicator
• 30808232001380: RT3 REACH9 Malleable Applicator
• 00808232001280: RT3 Surgical Hemostat
• 00808232001273: RT3 Surgical Hemostat
• 30808232000833: Spray Set