FDA.reportPublic FDA data

CutCure Sachet 0.068 fl oz

Primary DI
00860010047477
Brand
CutCure Sachet 0.068 fl oz
Company
Medcura, Inc.
Model
1
Published
2023-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K192667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192667000gel-e Flex+ gel OTCGel-E, Inc.2019-10-25QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010047477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010047477008600100474778600100474770860010047477

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
808674217
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010047460CutCure Tube 0.3 fl oz12023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
30841495150440QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930082QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930105QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930143QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20