ReliaTect® Post-Op Dressing with CHG

GUDID 20817138010511

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

AVERY DENNISON CORPORATION

Exudate-absorbent dressing, non-gel, antimicrobial, sterile

• Primary Device ID: 20817138010511
• NIH Device Record Key: aeb48982-bf91-4910-bb32-d6db6fd7e94e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliaTect® Post-Op Dressing with CHG
• Version Model Number: 0496-0568-76
• Company DUNS: 965754331
• Company Name: AVERY DENNISON CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817138010517 [Primary]
GS1	10817138010514 [Package]; Contains: 00817138010517; Package: Secondary (Carton) [5 Units]; In Commercial Distribution
GS1	20817138010511 [Package]; Contains: 10817138010514; Package: Tertiary (Shipper) [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163529

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [ReliaTect® Post-Op Dressing with CHG ]

• 20817138010511: ReliaTect® Post-Op Dressing with CHG, Large, 3.9 x 9.8 in (10 x 25 cm)
• 10817138010507: ReliaTect® Post-Op Dressing with CHG, Small, 3.2 x 5.9 in (8 x 15 cm)