FDA.reportPublic FDA data

ReliaTect® Post-Op Dressing with CHG

Primary DI
00817138010517
Brand
ReliaTect® Post-Op Dressing with CHG
Company
AVERY DENNISON CORPORATION
Model
0496-0568-76
Device description
ReliaTect® Post-Op Dressing with CHG, Large, 3.9 x 9.8 in (10 x 25 cm)
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K163529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163529000ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)Avery Dennison Corporation2017-03-29FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817138010514PackageGS15In Commercial Distribution
20817138010511PackageGS15In Commercial Distribution
00817138010517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081713801051410817138010514
2081713801051120817138010511
00817138010517008171380105178171380105170817138010517

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
965754331
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817138014980Cardinal Health™ Surgical Incise Drape with CHG60x 45 cm93772023-06-21
00817138014997Cardinal Health™ Surgical Incise Drape with CHG60x 85 cm93792023-06-21
00817138014973Cardinal Health™ Surgical Incise Drape with CHG30cm x 35 cm93752023-06-21
10817138014987Cardinal Health™ Surgical Incise Drape with CHG60x 45 cm93772023-06-21
10817138014994Cardinal Health™ Surgical Incise Drape with CHG60x 85 cm93792023-06-21
00817138010500ReliaTect® Post-Op Dressing with CHG 0496-0567-762018-08-31
10817138010507ReliaTect® Post-Op Dressing with CHG 0496-0567-762018-08-31
20817138010511ReliaTect® Post-Op Dressing with CHG 0496-0568-762018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22