2.5mm Mid-Reach Retinal Pencil

GUDID 05055272707664

KEELER LIMITED

Ophthalmic cryosurgical system, electronic

• Primary Device ID: 05055272707664
• NIH Device Record Key: 13a77c74-7c1b-4c98-8dfe-cf74db8c0448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.5mm Mid-Reach Retinal Pencil
• Version Model Number: 2509-P-8002
• Company DUNS: 210164398
• Company Name: KEELER LIMITED
• 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	05055272707664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062412

FDA Product Code

• HRN: Unit, Cryophthalmic, Ac-Powered

Sterilization

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

[05055272707664]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

On-Brand Devices [2.5mm Mid-Reach Retinal Pencil]

• 05055272711821: 2509-P-8022
• 05055272707664: 2509-P-8002