Coronet

GUDID 05060165016501

Carton Label - Eye Drain 400cc

NETWORK MEDICAL PRODUCTS LIMITED

Ophthalmic sponge

• Primary Device ID: 05060165016501
• NIH Device Record Key: 9e387fbd-4a63-4b66-9e50-fb0c11c454a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronet
• Version Model Number: 56-435
• Company DUNS: 458670304
• Company Name: NETWORK MEDICAL PRODUCTS LIMITED
• Device Count: 20
• DM Exempt: true
• 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	05060165016495 [Unit of Use]
GS1	05060165016501 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-06
• Device Publish Date: 2019-08-28

On-Brand Devices [Coronet]

• 05060165012756: Crawford Type Intubation Set
• 05060165012770: Canaliculus Intubation Set
• 05060165012183: COR. Artificial Anterior Chamber
• 05060165015924: DMEK System
• 05060165014385: CORONET EndoGlide Classic
• 05060165011704: 9.75 COR. Std Trephine
• 05060165011698: 9.50 COR. Std Trephine
• 05060165011681: 9.25 COR. Std Trephine
• 05060165011674: 9.00 COR. Std Trephine
• 05060165011667: 8.75 COR. Std Trephine
• 05060165011650: 8.50 COR. Std Trephine
• 05060165011643: 8.25 COR. Std Trephine
• 05060165011636: 8.00 COR. Std Trephine
• 05060165011629: 7.75 COR. Std Trephine
• 05060165011612: 7.50 COR. Std Trephine
• 05060165011605: 7.25 COR. Std Trephine
• 05060165011599: 7.00 COR. Std Trephine
• 05060165011582: 6.75 COR. Std Trephine
• 05060165011575: 6.50 COR. Std Trephine
• 05060165011568: 6.25 COR. Std Trephine
• 05060165011551: 6.00 COR. Std Trephine
• 05060165016181: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016174: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016167: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016150: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016143: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016136: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016129: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016112: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016105: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016099: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016082: ClearVue Recipient Vacuum Trephine for DALK
• 05060165016075: ClearVue Recipient Vacuum Trephine for DALK
• 05060165015429: 625mm - Long Handled Trephine - (E)
• 05060165015412: 600mm - Long Handled Trephine (E)
• 05060165015078: CORONET Exactor Trephine, 20mm
• 05060165014798: Traditional Trephine 5.50mm
• 05060165014712: 9.75mm Long Handled Trephine
• 05060165014583: 6.25mm Long Handle Trephine
• 05060165012213: 18 COR Exactor Trephine
• 05060165012206: 17 COR Exactor Trephine
• 05060165012190: 15 COR Exactor Trephine
• 05060165012145: 10.00 COR.L/H Trephine
• 05060165012138: 9.50 COR. L/H Trephine
• 05060165012121: 9.25 COR. L/H Trephine
• 05060165012114: 9.00 COR. L/H Trephine
• 05060165012091: 8.50 COR. L/H Trephine
• 05060165012084: 8.25 COR. L/H Trephine
• 05060165012077: 8.00 COR. L/H Trephine
• 05060165012060: 7.75 COR. L/H Trephine