FDA.reportPublic FDA data

ChitoGauze®, OTC, 3in x 48in

Primary DI
00870053000292
Brand
ChitoGauze®, OTC, 3in x 48in
Company
TRICOL BIOMEDICAL, INC.
Model
1
Catalog number
1030
Device description
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
Published
2021-04-14
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
K092357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092357000CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2Hem Con Medical Technologies, Inc.2009-08-25QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50870053000297PackageGS150In Commercial Distribution
00870053000292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5087005300029750870053000297
00870053000292008700530002928700530002920870053000292

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professional, non-bioabsorbableA 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.

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
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
00870053000360HemCon® OneStop™ Bandage, 2in x 2in, OTC111122021-05-05
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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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
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10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
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