ReliaTect® Post-Op Dressing with CHG

Basic Information

• Brand Name: ReliaTect® Post-Op Dressing with CHG
• Primary DI: 00817138010517
• Version / Model: 0496-0568-76
• Company Name: AVERY DENNISON CORPORATION
• Labeler DUNS: 965754331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-31
• Public Version: 2
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: aeb48982-bf91-4910-bb32-d6db6fd7e94e

Device Description

ReliaTect® Post-Op Dressing with CHG, Large, 3.9 x 9.8 in (10 x 25 cm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817138010511	GS1	Tertiary (Shipper)	5	In Commercial Distribution
Package	10817138010514	GS1	Secondary (Carton)	5	In Commercial Distribution
Primary	00817138010517	GS1

Premarket Submissions

Submission Number	Supplement Number
K163529	000