Sterile Micro Needle Cartridge

GUDID 08800017100784

Blister Pack

shenb Co., Ltd.

Radio-frequency skin surface treatment system

• Primary Device ID: 08800017100784
• NIH Device Record Key: 9f0535d7-6e15-4135-a2aa-cc7a2c58fdbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Micro Needle Cartridge
• Version Model Number: Exact RF TIP II
• Company DUNS: 690425442
• Company Name: shenb 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017100784 [Primary]
GS1	08800017100791 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	08800017100814 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211562

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2021-12-16
• Device Publish Date: 2021-12-08

On-Brand Devices [Sterile Micro Needle Cartridge]

• 08800017100784: Blister Pack
• 08800017100753: Blister Pack
• 08800017100678: Blister Pack
• 08800017100647: Blister Pack
• 08800017100616: Blister Pack
• 08800017100579: Blister Pack