D-STAT 3501

GUDID 20841156106536

D-Stat Dry Radial

TELEFLEX INCORPORATED

Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial Thrombin haemostatic agent, non-antimicrobial

• Primary Device ID: 20841156106536
• NIH Device Record Key: ba70be40-7177-4f05-9599-27464260e35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-STAT
• Version Model Number: IPN915420
• Catalog Number: 3501
• 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
• 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	10841156106539 [Primary]
GS1	20841156106536 [Package]; Contains: 10841156106539; 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: 2020-08-10
• Device Publish Date: 2020-07-31

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