FRONT LOADING SUPER-LOOP ELEC (BOX OF 5)

GUDID 00821925011335

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 00821925011335
• NIH Device Record Key: 97c21699-0353-4383-b53b-4f942f8e4fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRONT LOADING SUPER-LOOP ELEC (BOX OF 5)
• Version Model Number: 784415
• 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	00821925011335 [Package]; Contains: 00821925039506; Package: [5 Units]; In Commercial Distribution
GS1	00821925039506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031085

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-04

Devices Manufactured by Gyrus Acmi, Inc.

• 00821925041394 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR
• 00821925041400 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR
• 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