FDA.reportPublic FDA data

QUIKCLOT

Primary DI
10841495149488
Brand
QUIKCLOT
Company
TELEFLEX INCORPORATED
Model
188
Catalog number
188
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K120782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120782000INTERVENTIONAL HEMOSTATIC BANDAGEZ-Medica Corporation2013-03-20QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841495149485PackageGS110In Commercial Distribution
30841495149482PackageGS18In Commercial Distribution
10841495149488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084149514948520841495149485
3084149514948230841495149482
1084149514948810841495149488

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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
002348191
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
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
05060112313851LMA AIRWAY MANAGEMENTIPN0478971920302018-09-15
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25

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
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
06970206827845SURESPOT Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22