SURGIFLEX

GUDID 00821925000292

SURGIFLEX Suction-Irrigating Probe Reusable Electrode w/Luer Lok Connector Spatula, 5 mm X 32 cm

Gyrus Acmi, Inc.

Suction/irrigation tubing, reusable Suction/irrigation tubing, reusable Suction/irrigation tubing, reusable Suction/irrigation tubing, reusable Suction/irrigation tubing, reusable

• Primary Device ID: 00821925000292
• NIH Device Record Key: 1fcd2720-a692-408b-8872-b2af594df038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGIFLEX
• Version Model Number: 008041-901
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00821925000292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932626

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00821925000292]

Moist Heat or Steam Sterilization

[00821925000292]

Moist Heat or Steam Sterilization

[00821925000292]

Moist Heat or Steam Sterilization

[00821925000292]

Moist Heat or Steam Sterilization

[00821925000292]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-05

Devices Manufactured by Gyrus Acmi, Inc.

• 00821925000292 - SURGIFLEX: 2024-07-15SURGIFLEX Suction-Irrigating Probe Reusable Electrode w/Luer Lok Connector Spatula, 5 mm X 32 cm
• 00821925000292 - SURGIFLEX: 2024-07-15 SURGIFLEX Suction-Irrigating Probe Reusable Electrode w/Luer Lok Connector Spatula, 5 mm X 32 cm
• 00821925015708 - Gyrus ACMI: 2024-06-18 SCHUKNECHT CRESCENT FLUOROPLASTIC
• 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