FDA.reportPublic FDA data

SURESPOT Hemostatic Dressing

Primary DI
06970206828224
Brand
SURESPOT Hemostatic Dressing
Company
Jiangsu NewValue Medical Products Co.,Ltd.
Model
/
Device description
1pc/ bag, 5bags/box, 24boxes/case
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K213413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213413000Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.2023-09-01QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970206828221PackageGS124In Commercial Distribution
06970206828224PrimaryGS10
26970206828228Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697020682822116970206828221
06970206828224069702068282246970206828224
2697020682822826970206828228

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professional, non-bioabsorbableA non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Regulatory Flags#

DUNS number
544401775
Device count
5
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
true
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
06970206829191PreviClear Border Sacrum Transparent Gel DressingBorder2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingBorder2026-06-23
06970206820808kegel Hydrogel DressingIsland2026-06-22
06970206822390Rhino Rescue Hemostatic Dressing/2026-06-22
06970206823946Dr Perfect Hydrocolloid DressingIsland2026-06-22
06970206823960Dr Perfect Silicone Scar Sheets/2026-06-22
06970206823977kegel Hydrocolloid DressingIsland2026-06-22
06970206823984kegel Silicone Scar Sheets/2026-06-22
06970206827067Ourmed Foam DressingBorder2026-06-22
06970206827074Ourmed Foam DressingBorder2026-06-22
06970206827081Ourmed Foam DressingBorder2026-06-22
06970206827098Ourmed Foam DressingBorder2026-06-22
06970206827104Ourmed Foam DressingBorder2026-06-22
06970206827845SURESPOT Hemostatic Dressing/2026-06-22
06970206828149Ourmed Foam DressingBorder2026-06-22
06970206828156Ourmed Foam DressingBorder2026-06-22
06970206828163Ourmed Foam DressingBorder2026-06-22
06970206828170Ourmed Foam DressingBorder2026-06-22
06970206828217SURESPOT Hemostatic Dressing/2026-06-22
06970206823830Hydrocolloid DressingStandard2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970206822390Rhino Rescue Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22
06970206827845SURESPOT Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22
06970206828217SURESPOT Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22
00860007891168TRAUMAGEL®Cresilon, Inc.QSY2026-06-01
00017276241709Rapid SealAso LLCQSY2026-05-27
10841495149679QUIKCLOTTELEFLEX INCORPORATEDQSY2026-05-11
00050428142530CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDQSY2026-04-23
10841495149648QUIKCLOTTELEFLEX INCORPORATEDQSY2026-04-09
14026704935892QUIKCLOTTELEFLEX INCORPORATEDQSY2026-04-09
00834061005236StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005243StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005250StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005267StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005274StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005281StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005298StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005304StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005366StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005373StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
10841495150385QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150408QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150422QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150446QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930088QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930101QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930149QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930163QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150389QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150402QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150426QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20