Single-Use Flexible Rhinolaryngoscope

GUDID 06972197480801

Hunan Vathin Medical Instrument Co., Ltd

Flexible video otorhinolaryngoscope, single-use

• Primary Device ID: 06972197480801
• NIH Device Record Key: 8e45bc0b-da71-458b-b934-77494b71a95c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Flexible Rhinolaryngoscope
• Version Model Number: RL-S1E00
• Company DUNS: 554484862
• Company Name: Hunan Vathin Medical Instrument 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: 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	06972197480801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221581

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [Single-Use Flexible Rhinolaryngoscope]

• 06972197480801: RL-S1E00
• 06972197480795: RL-S1800
• 06972197480788: RL-S1E01
• 06972197480771: RL-S1801
• 06972197480580: RL-E1E01
• 06972197480481: RL-E1E00
• 06972197480467: RL-E1801
• 06972197480405: RL-E1800