D-STAT

Basic Information

• Brand Name: D-STAT
• Primary DI: 10841156102005
• Version / Model: IPN913524
• Catalog Number: 3001
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 3
• Public Version Date: 2024-01-23
• Public Version Status: Update
• Public Device Record Key: 14ddc0ee-e156-4129-ba83-01681bd37950

Device Description

D-Stat Dry

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSX	Hemostatic wound dressing with thrombin or other biologics	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64781	Thrombin haemostatic agent, non-antimicrobial	A non-bioabsorbable device containing animal-derived thrombin, without an antimicrobial agent, intended to be used by a healthcare professional for topical application to a surgical wound (e.g., during percutaneous vascular access), to facilitate local haemostasis primarily through thrombin activation of blood clotting mechanisms. It is typically available in the form of bandage, pad, or sponge that can be applied directly to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30841156102009	GS1	Box	10	In Commercial Distribution
Primary	10841156102005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061219	000