4 chamber extension zipper

GUDID 18809802640655

ARM EXTENSION ZIPPER 1ea [One polybag]

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 18809802640655
• NIH Device Record Key: ec49b44e-f18c-47c4-bb18-fd6c6a1213d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 chamber extension zipper
• Version Model Number: 4EAGF02
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF CO.,LTD.
• 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: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809802640658 [Primary]
GS1	18809802640655 [Package]; Contains: 08809802640658; Package: Box [10 Units]; In Commercial Distribution
GS1	28809802640652 [Package]; Contains: 08809802640658; Package: Box [20 Units]; In Commercial Distribution
GS1	38809802640659 [Package]; Contains: 08809802640658; Package: Box [30 Units]; In Commercial Distribution
GS1	48809802640656 [Package]; Contains: 08809802640658; Package: Box [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150033

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [4 chamber extension zipper]

• 18809802640662: CENTER BODY EXTENSION ZIPPER 2ea [One polybag]
• 18809802640655: ARM EXTENSION ZIPPER 1ea [One polybag]
• 18809802640648: LEG EXTENSION ZIPPER XXLarge 2ea [One polybag]
• 18809802640631: LEG EXTENSION ZIPPER XLarge 2ea [One polybag]
• 18809802640624: LEG EXTENSION ZIPPER Large 2ea [One polybag]