Home GUDID 00812480010307 NA
Primary DI 00812480010307
Brand NA
Company MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Model 4625CE
Catalog number 4625CE
Device description Tubing Set, Posterior Vitreous Cutter, Non-Sterile
Published 2017-06-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered Ophthalmic 2 HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10812480010304 Package GS1 3 Not in Commercial Distribution 00812480010307 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10812480010304 10812480010304 00812480010307 00812480010307 812480010307 0812480010307
GMDN Terms# Term, Definition table Term Definition Vitrectomy system handpiece A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Length 79 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 100 Percent (%) Relative Humidity Handling Environment Temperature -40 Degrees Celsius 70 Degrees Celsius Storage Environment Humidity 10 Percent (%) Relative Humidity 100 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 790265227 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10757770060464 Bausch + Lomb Bausch & Lomb Incorporated HQE 2026-04-09 10757770060471 Bausch + Lomb Bausch & Lomb Incorporated HQE 2026-04-09 10757770060488 Bausch + Lomb Bausch & Lomb Incorporated HQE 2026-04-09 00380650003294 UNITY Alcon Laboratories, Inc. HQE 2025-04-08 00380650003300 UNITY Alcon Laboratories, Inc. HQE 2025-04-08 00380650003317 UNITY Alcon Laboratories, Inc. HQE 2025-04-08 00380650003614 UNITY Alcon Laboratories, Inc. HQE 2025-04-08 08717872036540 27G Two Dimensional Cutter – 20k CPM D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-04-01 08717872036526 EVA Cartridge with 0.5 L Collection Bag D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 08717872036588 Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 08717872036489 EVA NEXUS™ Irrigation and Aux. Aspiration Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 08717872036496 EVA NEXUS™ Infusion Giving Set D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 08717872036502 EVA Nexus™ Irrigation Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 08717872036618 EVA Nexus™ Aux. Aspiration Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 08717872036625 EVA NEXUS™ cartridge with 0,5 L collection bag D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2025-03-31 00380650003324 UNITY Alcon Laboratories, Inc. HQE 2024-11-19 00380650003348 UNITY Alcon Laboratories, Inc. HQE 2024-11-19 08717872034713 CUSTOM TDC VITREC.PACK VGP 25G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-09-27 00380650001252 UNITY Alcon Laboratories, Inc. HQE 2024-07-02 08717872035109 EVA NEXUS™ Posterior 23G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035116 EVA NEXUS™ Posterior 25G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035123 EVA NEXUS™ Posterior 27G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035307 EVA NEXUS™ Posterior 23G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035314 EVA NEXUS™ Posterior 25G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035321 EVA NEXUS™ Posterior 27G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035338 EVA NEXUS™ Combined 23G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035345 EVA NEXUS™ Combined 25G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872035352 EVA NEXUS™ Combined 27G TDC Pack D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-21 08717872034652 EVA Vitrectomy Pack VGPC Input 20G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-20 08717872034683 EVA TDC Vitrectomy Pack VGPC Input 23G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. HQE 2024-02-20
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