Diathermy cable, for 1120 / 1121 / 1122 / 1120-0.5 / 1120-D-0.5 and 1120-0.6 han 1120.A

GUDID 08717872000411

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

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 08717872000411
• NIH Device Record Key: fd2f9e66-6cbb-4519-a73e-5b39b2c9649f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diathermy cable, for 1120 / 1121 / 1122 / 1120-0.5 / 1120-D-0.5 and 1120-0.6 han
• Version Model Number: 1120.A
• Catalog Number: 1120.A
• 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	08717872000411 [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

[08717872000411]

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

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

• 18717872034710 - CUSTOM TDC VITREC.PACK VGP 25G: 2024-10-07
• 18717872034932 - 23G High Flow infusion line: 2024-02-29
• 18717872034949 - 25G High Flow infusion line: 2024-02-29
• 18717872034956 - 27G High Flow infusion line: 2024-02-29
• 18717872035106 - EVA NEXUS™ Posterior 23G TDC Pack: 2024-02-29
• 18717872035113 - EVA NEXUS™ Posterior 25G TDC Pack: 2024-02-29
• 18717872035120 - EVA NEXUS™ Posterior 27G TDC Pack: 2024-02-29
• 18717872035304 - EVA NEXUS™ Posterior 23G TDC Pack: 2024-02-29