Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 30 P.S.I., max. 1267.NMD06

GUDID 08717872001418

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

Ophthalmic surgical instrument handle, pneumatic

• Primary Device ID: 08717872001418
• NIH Device Record Key: d6a5fdf5-9e1f-4215-af9b-aa80d32b3dc5
• Commercial Distribution Discontinuation: 2023-09-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 30 P.S.I., max.
• Version Model Number: 1267.NMD06
• Catalog Number: 1267.NMD06
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 6
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08717872001418 [Primary]
GS1	18717872001415 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081877

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-15
• Device Publish Date: 2016-09-30

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

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• 08717872037110 - 27G Extendible subretinal injection cannula (41G): 2025-10-06
• 18717872035496 - TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm): 2025-04-09
• 18717872035540 - TotalView Chandelier for cannula system.(25 gauge / 0.5 mm): 2025-04-09
• 18717872036547 - 27G Two Dimensional Cutter – 20k CPM: 2025-04-09
• 08717872034720 - EVA Custom TDC Vitrectomy Pack VGPC Input 27G: 2025-04-08
• 18717872035397 - Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4: 2025-04-08
• 18717872035403 - Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9: 2025-04-08