FDA.reportPublic FDA data

Responder® Polysaccharide Hemostat

Primary DI
10899010002886
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
OTC
false
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.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850074534044Responder® Polysaccharide HemostatRP00032025-08-15
00899010002865Responder® Polysaccharide HemostatRP00032024-12-31
00899010002698Responder® Polysaccharide HemostatRP00032024-12-31
00899010002889Responder® Polysaccharide HemostatRP00252024-06-03
00899010002834Responder® Polysaccharide HemostatRP00102024-05-31

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