InstaClear

GUDID 00821925041394

SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR

Gyrus Acmi, Inc.

Flexible fibreoptic nasopharyngoscope

• Primary Device ID: 00821925041394
• NIH Device Record Key: 354e7822-4b9a-4880-ac48-3a5bb962f346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaClear
• Version Model Number: LCS4K00UNOL
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925041394 [Package]; Contains: 00821925041462; Package: [5 Units]; In Commercial Distribution
GS1	00821925041462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152531

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: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [InstaClear]

• 00821925041455: SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041448: SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
• 00821925041431: SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041424: SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
• 00821925041417: SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041400: SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR
• 00821925041394: SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR