FDA.report

Responder® Polysaccharide Hemostat

Primary DI
00850074534044
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
2025-08-15
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

Related Records

Product Codes

CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications

CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions

SubmissionSupplement
K240454000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240454000RESPONDER® Polysaccharide HemostatStarch Medical, Inc.2024-03-15QSY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850074534044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074534044008500745340448500745340440850074534044

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020462087
Device count
1
DM exempt
false
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 DIBrandModelCatalogPublished
00899010002698Responder® Polysaccharide HemostatRP00032024-12-31
10899010002886Responder® Polysaccharide HemostatRP00252024-06-03
00899010002834Responder® Polysaccharide HemostatRP00102024-05-31

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