Titanium Henderson Degree Gauge

GUDID 00840096200638

KATALYST SURGICAL LLC

Ophthalmic angular gauge, reusable

• Primary Device ID: 00840096200638
• NIH Device Record Key: 2784b265-09e7-40a1-a3ad-cfd0b393fdcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titanium Henderson Degree Gauge
• Version Model Number: 8505
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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	00840096200638 [Primary]

FDA Product Code

• HMR: Marker, Ocular

Sterilization

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

[00840096200638]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-06-24

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