RAINS FRONTAL SINUS STENT LARGE SILICONE

GUDID 00821925022508

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: 00821925022508
• NIH Device Record Key: ebb106b9-28af-42f1-8883-6bff0ec56d85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAINS FRONTAL SINUS STENT LARGE SILICONE
• Version Model Number: 70890931
• 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	00821925022508 [Package]; Contains: 00821925034716; Package: [6 Units]; In Commercial Distribution
GS1	00821925034716 [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.

• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)