Janach

GUDID 05060165019205

Janach PVA Spears 10's

NETWORK MEDICAL PRODUCTS LIMITED

Ophthalmic sponge

• Primary Device ID: 05060165019205
• NIH Device Record Key: 9d2e6390-7c8f-4ccb-8aa2-dc56fd94f09f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Janach
• Version Model Number: J4491
• Company DUNS: 458670304
• Company Name: NETWORK MEDICAL PRODUCTS 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	05060165019205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130117

FDA Product Code

• HOZ: Sponge, 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: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [Janach]

• 05060165019229: J4494.1 - Janach Corneal Light Shield 8mm
• 05060165019205: Janach PVA Spears 10's
• 05056100711839: 2-400P Janach PVA spears 5
• 05056100707641: J4499 Janach PVA LASIK Eye Drain 20 Pouches per Carton Sterile