D-STAT 3001

GUDID 30841156102009

D-Stat Dry

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

• Primary Device ID: 30841156102009
• NIH Device Record Key: 14ddc0ee-e156-4129-ba83-01681bd37950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-STAT
• Version Model Number: IPN913524
• Catalog Number: 3001
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841156102005 [Primary]
GS1	30841156102009 [Package]; Contains: 10841156102005; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061219

FDA Product Code

• 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-24
• Device Publish Date: 2022-12-08

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