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Acteon

FDA UDI

Class U (US FDA UDI)

by Acteon Manufacturing

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Non-organic haemostatic agent FDA UDI
Device Name
HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action. Box with 2 x 2g multiple use syringes of HEMOSTASYL paste FDA UDI
Model / Reference
Hemostasyl syringes FDA UDI
Description
HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action. Box with 2 x 2g multiple use syringes of HEMOSTASYL paste FDA UDI

Identifiers

Catalog Number
246050 FDA UDI
Primary DI / UDI-DI
03760243000935 FDA UDI
510(k) Number
K082116 FDA UDI
FDA Product Code
MVL FDA UDI
GMDN Term
Non-organic haemostatic agent FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Acteon by Acteon Manufacturing — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 55f1bf63-eccd-4c5b-89eb-84edcf5bf970 38 fields · synced May 30, 2026