FDA.reportPublic FDA data

GuardaCare®XR Surgical, 4in x 4in, 8ply

Primary DI
00870053000117
Brand
GuardaCare®XR Surgical, 4in x 4in, 8ply
Company
TRICOL BIOMEDICAL, INC.
Model
1
Catalog number
1032
Device description
HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch.
Published
2021-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K103641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103641000GUARDACAREHem Con Medical Technologies, Inc.2011-06-16QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20870053000111PackageGS110In Commercial Distribution
50870053000112PackageGS110In Commercial Distribution
00870053000117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087005300011120870053000111
5087005300011250870053000112
00870053000117008700530001178700530001170870053000117

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature11 Degrees Celsius26 Degrees Celsius

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
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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