← Back to catalogue

Hemopore

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
Hemopore FDA UDI
Generic Name
ENT space-occupying dressing, animal-derived FDA UDI
Model / Reference
5400222208S FDA UDI

Identifiers

Catalog Number
5400-222-208S FDA UDI
Primary DI / UDI-DI
07613327500486 FDA UDI
FDA Product Code
LYA FDA UDI
GMDN Term
ENT space-occupying dressing, animal-derived FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: ENT space-occupying dressing, animal-derived

Hemopore is a sterile, bioabsorbable dressing designed to help heal tissue and control bleeding after ear, nose, throat (ENT) surgery or trauma. It contains animal-derived components and microbe-derived biosynthetic components, making it suitable for single-use implantation in nasal/sinus applications.

Similar devices

Also classified as ENT space-occupying dressing, animal-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI e5788d0d-8f93-4ca9-8962-a9adbf74e93e 35 fields · synced Jul 30, 2026