D-STAT 3005

GUDID 20841156105577

D-Stat Dry Silver Clear

TELEFLEX INCORPORATED

Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial Thrombin haemostatic agent, antimicrobial

• Primary Device ID: 20841156105577
• NIH Device Record Key: 17512cb7-0f1a-4bb0-8027-8f53696fe8b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-STAT
• Version Model Number: IPN001446
• Catalog Number: 3005
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841156105570 [Primary]
GS1	20841156105577 [Package]; Contains: 10841156105570; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• FRO: Dressing, wound, drug
• QSX: Hemostatic wound dressing with thrombin or other biologics

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [D-STAT]

• 30841156101743: Dstat RadBand
• 20841156106536: D-Stat Dry Radial
• 20841156105591: D-Stat2 Dry
• 20841156105577: D-Stat Dry Silver Clear
• 20841156105560: D-Stat Dry Silver
• 20841156105621: D-Stat Dry Radial
• 20841156105584: D-Stat Clear
• 30841156102009: D-Stat Dry
• 20841156109087: D-Stat Flowable, 5pk, US