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D-Stat

FDA UDI

Class U (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
D-STAT FDA UDI
Generic Name
Thrombin haemostatic agent, non-antimicrobial FDA UDI
Device Name
D-Stat Dry Radial FDA UDI
Model / Reference
IPN001459 FDA UDI
Description
D-Stat Dry Radial FDA UDI

Identifiers

Catalog Number
3501 FDA UDI
Primary DI / UDI-DI
10841156105624 FDA UDI
FDA Product Code
QSX FDA UDI
GMDN Term
Thrombin haemostatic agent, non-antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Thrombin haemostatic agent, non-antimicrobial

D-Stat by Teleflex Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombin haemostatic agent, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI a2715e73-7db4-4db5-9d77-2b04fe4fca88 35 fields · synced May 30, 2026