ALCON 8065000388

GUDID 10380650003888

Remote Control Aseptic Transfer Pouch (RCATII)

Alcon Laboratories, Inc.

Medical equipment drape, single-use

• Primary Device ID: 10380650003888
• NIH Device Record Key: 0ae5ef89-f266-4b5c-b10c-e2924975acf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALCON
• Version Model Number: 00380650003881
• Catalog Number: 8065000388
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650003881 [Primary]
GS1	10380650003888 [Package]; Contains: 00380650003881; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• HMT: Drape, Patient, Ophthalmic

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: 2024-07-10
• Device Publish Date: 2024-07-02

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