← Back to catalogue

Responder® Polysaccharide Hemostat

FDA UDI

Class U (US FDA UDI)

by Starch Medical Inc.

Identity

Trade Name
Responder® Polysaccharide Hemostat FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
Device Name
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions. FDA UDI
Model / Reference
RP0003 FDA UDI
Description
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions. FDA UDI

Identifiers

Primary DI / UDI-DI
00850074534044 FDA UDI
510(k) Number
K240454 FDA UDI
FDA Product Code
QSY FDA UDI
GMDN Term
Plant polysaccharide haemostatic agent, bioabsorbable 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

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Category: Plant polysaccharide haemostatic agent, bioabsorbable

Responder® Polysaccharide Hemostat by Starch Medical Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plant polysaccharide haemostatic agent, bioabsorbable.

Cleared under the same submission

K240454 also covers:

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
Starch Medical Inc.

Sources (1)

  • FDA UDI bdcf831f-dc97-460e-ab2e-708714e52de0 34 fields · synced May 30, 2026