FDA.reportPublic FDA data

HemCon® OneStop™ Bandage, 2in x 2in, OTC

Primary DI
00870053000360
Brand
HemCon® OneStop™ Bandage, 2in x 2in, OTC
Company
TRICOL BIOMEDICAL, INC.
Model
1
Catalog number
1112
Device description
OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulationtherapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
Published
2021-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150916000HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PROHem Con Medical Technologies, Inc.2015-11-10QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50870053000365PackageGS150In Commercial Distribution
00870053000360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5087005300036550870053000365
00870053000360008700530003608700530003600870053000360

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professionalA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9712231000sales@tricolbiomedical.com

Regulatory Flags#

DUNS number
080240553
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00870053000018"ChitoGauze®XR PRO 3"" x 4 yds Prometheus"110892021-01-27
00870053000049HemCon ChitoDot®, 3/4in110932021-04-14
00870053000131"ChitoGauze®XR PRO 3"" x 4 yds"110902021-01-27
00870053000292ChitoGauze®, OTC, 3in x 48in110302021-04-14
00870053000308ChitoGauzeXL, OTC, 3in x 4yd110252021-04-14
00870053000315HemCon ChitoGauze XR2 Pro, 3in x 4yd111012021-04-14
00870053000339HemCon® OneStop™ Bandage, 2in x 2in111052021-05-05
00870053000353HemCon® OneStop™ Bandage, 2in x 2in111142020-10-15
00870053000407HemCon® OneStop® Vascular, 2in x 2in111032022-04-05
00870053000414HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit111042022-04-05
00870053000568ChitoGauzeXR PRO, 3in x 4yds110202024-05-30
00870053001015HemCon® Bandage PRO, 4in x 4in110032020-10-14
00870053001121HemCon ChitoFlex®, 1in x 3in110082021-04-14
00870053001299HemCon® Patch PRO, 1.5in x 1.5in110042020-10-14
00870053001855HemCon® Patch PRO, 2in x 2in110052020-10-14
00870053001268HemCon® Strip PRO, 1in x 4in12021-07-09
00870053000117GuardaCare®XR Surgical, 4in x 4in, 8ply110322021-07-08
00870053001367GuardaCare® PRO, 4in x 4in, 8ply110132021-04-14
00870053001350HemCon GuardaCare® PRO, 2in x 2in, 8ply110122020-12-10
00870053000322HemCon® OneStop™ Vascular111022020-09-22

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