Home GUDID 00899010002698 Responder® Polysaccharide Hemostat
Primary DI 00899010002698
Brand Responder® Polysaccharide Hemostat
Company Starch Medical Inc.
Model RP0003
Device description RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions.
Published 2024-12-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00899010002698 Package GS1 3 In Commercial Distribution 00899010002865 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00899010002698 00899010002698 899010002698 0899010002698 00899010002865 00899010002865 899010002865 0899010002865
GMDN Terms# Term, Definition table Term Definition Plant polysaccharide haemostatic agent, bioabsorbable A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.
Regulatory Flags# DUNS number 020462087 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850074534044 Responder® Polysaccharide Hemostat RP0003 2025-08-15 00899010002865 Responder® Polysaccharide Hemostat RP0003 2024-12-31 00899010002889 Responder® Polysaccharide Hemostat RP0025 2024-06-03 10899010002886 Responder® Polysaccharide Hemostat RP0025 2024-06-03 00899010002834 Responder® Polysaccharide Hemostat RP0010 2024-05-31
Other Devices Sharing Product Codes# 
starchmedical.com