Exo diathermy handle with 45° curved tip, diameter 1.3 mm. 1122

GUDID 08717872000480

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 08717872000480
• NIH Device Record Key: 9c61bf0e-9a7d-4c0a-802d-3f9fb332998f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exo diathermy handle with 45° curved tip, diameter 1.3 mm.
• Version Model Number: 1122
• Catalog Number: 1122
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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	08717872000480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQR: Apparatus, Cautery, Radiofrequency, Ac-Powered

Sterilization

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

[08717872000480]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-18
• Device Publish Date: 2016-09-24

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