GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5

GUDID 10840096200994

KATALYST SURGICAL LLC

Ophthalmic knife, reusable

• Primary Device ID: 10840096200994
• NIH Device Record Key: 2cb3bdef-aa66-44d4-834d-071fcda09e19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5
• Version Model Number: 7900-P75-60A
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840096200994 [Primary]

FDA Product Code

• HNN: Knife, Ophthalmic

Sterilization

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

[10840096200994]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-27
• Device Publish Date: 2019-06-19

On-Brand Devices [GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5]

• 10840096200994: 7900-P75-60A
• 00840096207095: GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5