PalmScan A2000 Pro with IOL Calculator 900-0006-02-2

GUDID 00853569007009

A2000 Portable A-Scan Ultrasonic or Ophthalmic use Classification Name : Transduce, Ultrasonic, Diagnostic

Micro Medical Devices, Inc.

Ophthalmic ultrasound imaging transducer

• Primary Device ID: 00853569007009
• NIH Device Record Key: 35358bca-03c0-4ab6-8b11-a8de59ea7a46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PalmScan A2000 Pro with IOL Calculator
• Version Model Number: A2000
• Catalog Number: 900-0006-02-2
• Company DUNS: 146767400
• Company Name: Micro Medical Devices, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853569007009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043287

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-24
• Device Publish Date: 2024-01-16

Devices Manufactured by Micro Medical Devices, Inc.

• 00853569007009 - PalmScan A2000 Pro with IOL Calculator: 2024-01-24A2000 Portable A-Scan Ultrasonic or Ophthalmic use Classification Name : Transduce, Ultrasonic, Diagnostic
• 00853569007009 - PalmScan A2000 Pro with IOL Calculator: 2024-01-24 A2000 Portable A-Scan Ultrasonic or Ophthalmic use Classification Name : Transduce, Ultrasonic, Diagnostic
• 00853569007016 - PalmScan P2000: 2023-08-24 P 2000 Portable Pachymeter Classification Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 00853569007023 - PalmScan P2000FP: 2023-08-24 P2000 FP is a Portable Pachymeter SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 00853569007030 - PalmScan AP2000: 2023-08-24 A 2000 portable A-scan biometer; AP 2000 Portable Ascan / Pachymeter; P 2000 Portable Pachymeter Classification Name: SYSTEM, IM
• 00853569007047 - PalmScan K2000: 2023-08-24 Portable Keratometer TOPOGRAPHER, CORNEAL, BATTERY POWERED
• 00853569007108 - PalmScan VF2000: 2023-08-24 Virtual reality based battery powered automatically operated, diagnostic, ophthalmic instrument intended for assessing the exten
• 00853569007115 - PalmScan PM2000: 2023-08-24 Advanced VR Pupilometer PUPILLOGRAPH
• 00853569007122 - PalmScan DA2000: 2023-08-24 Dark Adaptometer