Alcon

GUDID 10380650001471

GRAVITY FMS, BASIC

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10380650001471
• NIH Device Record Key: f558cd74-daf3-4d63-b97b-67808819097c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcon
• Version Model Number: 00380650001474
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, 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: true
• 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	00380650001474 [Primary]
GS1	10380650001471 [Package]; Contains: 00380650001474; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121555

FDA Product Code

• HQC: Unit, phacofragmentation

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: 2021-10-13
• Device Publish Date: 2021-10-05

On-Brand Devices [Alcon]

• 00380659909498: Alcon Online Barrett Toric IOL Calculator
• 10380658202016: Infusion Cannula
• 10380658201019: Infusion Cannula
• 10380658075504: Scleral Plugs, Contains: 6 Plugs, 3 each 1.08mm (19GA) (GOLD) & 3 each .89mm (20 GA) (Silver) pl
• 10380658070011: GFX Infusion Line
• 00380658036027: Sterilization Tray
• 10380657529183: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
• 10380657529176: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
• 10380657522474: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 45° KELMAN* ABS* Mini Tip
• 10380657522467: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 30° KELMAN* ABS* Mini Tip
• 10380657522450: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° KELMAN* ABS* Mini Tip
• 10380657522443: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° KELMAN* ABS* Mini Tip
• 10380657522177: GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
• 10380657522160: GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
• 10380657522153: GRAVITY FMS W/ INTREPID* NANO SLEEVES, 0.9 MM Tipless
• 10380657522146: GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9 MM Tipless
• 10380657522139: GRAVITY FMS W/ 0.9 MM INFUSION SLEEVES, 0.9 MM Tipless
• 10380657522122: GRAVITY FMS, BASIC
• 10380657522030: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
• 10380657522023: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
• 10380657522016: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
• 10380657522009: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
• 10380657521996: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 45° OZIL* 12 Mini-Flared ABS* Tip
• 10380657521989: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 30° OZIL* 12 Mini-Flared ABS* Tip
• 10380657521972: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 45° KELMAN* Mini-Flared ABS* Tip
• 10380657521965: ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 30° KELMAN* Mini-Flared ABS* Tip
• 10380657521958: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° OZIL* 12 Mini-Flared ABS* Tip
• 10380657521941: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° OZIL* 12 Mini-Flared ABS* Tip
• 10380657521934: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° KELMAN* Mini-Flared ABS* Tip
• 10380657521927: ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° KELMAN* Mini-Flared ABS* Tip
• 10380657521910: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° OZIL* 12 Mini-Flared ABS* Tip
• 10380657521903: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 30° OZIL* 12 Mini-Flared ABS* Tip
• 10380657521897: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° KELMAN* Mini-Flared ABS* Tip
• 10380657521880: ACTIVE FMS W/ 0.9MM INFUSION SLEEVES, 0.9MM 30° KELMAN* Mini-Flared ABS* Tip
• 10380657521873: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° KELMAN* Tapered ABS* Tip
• 10380657521866: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 30° KELMAN* Tapered ABS* Tip
• 10380657521859: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° KELMAN* ABS* Tip
• 10380657521842: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9 MM 30° KELMAN* ABS* Tip
• 10380657521835: ACTIVE FMS W/ INTREPID NANO SLEEVES, 0.9 MM Tipless
• 10380657521828: ACTIVE FMS W/ INTREPID ULTRA SLEEVES, 0.9 MM Tipless
• 10380657521811: ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9 MM Tipless
• 10380657521804: ACTIVE FMS, BASIC
• 10380657521507: 23GA Sutured Infusion Cannula, 4mm w/Tray; 64mm (23GA) Infusion Cannula Sutured w/Tray
• 10380657518910: 25GA Enhanced Retention Valved Entry System (3-CT)
• 10380657518897: 23GA Enhanced Retention Valved Entry System (3-CT)
• 10380657518019: 23 Ga 6mm Valved Trocar Cannula Entry System, 3 ct
• 10380657518002: 23 Ga 6mm Valved Trocar Cannula Entry System, 1 ct
• 10380657517821: 25 Ga 6mm Valved Trocar Cannula Entry System, 1 ct
• 10380657517784: 25 Ga 6mm Valved Trocar Cannula Entry System, 3 ct
• 10380657517081: 27+ TM Flexible Tip Laser Probe