FDA.reportPublic FDA data

CutCure Tube 0.3 fl oz

Primary DI
00860010047460
Brand
CutCure Tube 0.3 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
00860010047460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010047460008600100474608600100474600860010047460

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
00860010047477CutCure Sachet 0.068 fl oz12023-11-09

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Primary DI, Brand, Company table
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