RAINS FRONTAL SINUS STENT STANDARD SIZE RADIO-OPAQUE SILICONE

GUDID 00821925022515

Gyrus Acmi, Inc.

Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Nasal cavity stent, removable, prefabricated Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived

• Primary Device ID: 00821925022515
• NIH Device Record Key: d55ad285-5b86-411e-b8d1-e475fa706cc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAINS FRONTAL SINUS STENT STANDARD SIZE RADIO-OPAQUE SILICONE
• Version Model Number: 70890932
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925022515 [Package]; Contains: 00821925034303; Package: [6 Units]; In Commercial Distribution
GS1	00821925034303 [Primary]

FDA Product Code

• KAM: CANNULA, SINUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-09-13

Devices Manufactured by Gyrus Acmi, Inc.

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• 00821925041417 - InstaClear: 2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041424 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
• 00821925041431 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041448 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
• 00821925041455 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG