FDA.reportPublic FDA data

QUIKCLOT

Primary DI
10841495149525
Brand
QUIKCLOT
Company
TELEFLEX INCORPORATED
Model
IPN930343
Catalog number
458
Device description
QuikClot Hemostatic Dressing, 2x2
Published
2025-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K123387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123387000QUIKCLOT HEMOSTATIC DRESSINGZ-Medica, LLC2013-04-12QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841495149522PackageGS110In Commercial Distribution
30841495149529PackageGS124In Commercial Distribution
10841495149525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084149514952220841495149522
3084149514952930841495149529
1084149514952510841495149525

GMDN Terms#

Term, Definition table
TermDefinition
Non-organic haemostatic agentA non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Environment Temperature
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841495149457QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149464QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149471QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149488QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149495QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149501QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149518QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149549QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149563QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149587QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149600QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149624QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930644QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930651QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930668QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930675QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930682QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930699QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930705QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930729QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930736QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930743QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930750QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930767QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930774QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930781QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930798QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930804QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930811QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
06970206822390Rhino Rescue Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22