FDA.reportPublic FDA data

Responder® Polysaccharide Hemostat

Primary DI
00899010002889
Brand
Responder® Polysaccharide Hemostat
Company
Starch Medical Inc.
Model
RP0025
Device description
RESPONDER® Polysaccharide Hemostat is intended to be used to achieve hemostasis in emergency situations forthe temporary control of severe topical bleeding.
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220525000RESPONDER Polysaccharide HemostatStarch Medical, Inc.2023-12-04QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10899010002886PackageGS110In Commercial Distribution
00899010002889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089901000288610899010002886
00899010002889008990100028898990100028890899010002889

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850074534044Responder® Polysaccharide HemostatRP00032025-08-15
00899010002865Responder® Polysaccharide HemostatRP00032024-12-31
00899010002698Responder® Polysaccharide HemostatRP00032024-12-31
10899010002886Responder® Polysaccharide HemostatRP00252024-06-03
00899010002834Responder® Polysaccharide HemostatRP00102024-05-31

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