Avance 662352

GUDID 07323190193516

Mölnlycke Health Care AB

Negative-pressure wound therapy system dressing set

• Primary Device ID: 07323190193516
• NIH Device Record Key: b2dc3ef5-0d03-4423-b5a4-285ae83af79b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avance
• Version Model Number: 662352-01
• Catalog Number: 662352
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• 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	07323190047314 [Primary]
GS1	07323190193509 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	07323190193516 [Package]; Contains: 07323190047314; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161797

FDA Product Code

• OMP: negative pressure wound therapy Powered suction pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-12

On-Brand Devices [Avance]

• 07332551967499: 66499
• 07323190160570: 773014-00
• 07323190160532: 773013-00
• 07323190160495: 772013-00
• 07323190154432: 772009-00
• 07323190154395: 772003-00
• 07323190193752: 662752-01
• 07323190193684: 662652-01
• 07323190193660: 662552-01
• 07323190193639: 662452-01
• 07323190193592: 664352-01
• 07323190193578: 664252-01
• 07323190193530: 664152-01
• 07323190193516: 662352-01
• 07323190193486: 662252-01
• 07323190193448: 662152-01