Endo-diathermy handle, straight pointed tip.(25 gauge / 0.5 mm) 1120.05

GUDID 08717872000398

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

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 08717872000398
• NIH Device Record Key: 7bcdce6a-b16c-4487-ba8c-3ce3fbed23a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-diathermy handle, straight pointed tip.(25 gauge / 0.5 mm)
• Version Model Number: 1120.05
• Catalog Number: 1120.05
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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	08717872000398 [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

[08717872000398]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-17
• Device Publish Date: 2016-09-24

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