GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Trun

GUDID 00840096215168

GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Width

KATALYST SURGICAL LLC

Ophthalmic knife, reusable

• Primary Device ID: 00840096215168
• NIH Device Record Key: 76c9e98f-0489-448b-92eb-d0336f8b5a0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Trun
• Version Model Number: 7924-P1-60T
• 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	00840096215168 [Primary]

FDA Product Code

• HNN: Knife, Ophthalmic

Sterilization

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

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

[00840096215168]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Trun]

• 10840096215165: GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Wid
• 00840096215168: GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Wid