AccessGUDID - DEVICE: EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector (08717872034447)

GUDID

Device Identifier (DI) Information

Brand Name: EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector
Version or Model: 9000.COMU3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872034447
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 407522184 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45072	Phacoemulsification/vitrectomy system	An assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQC	Unit, Phacofragmentation
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
HQF	Laser, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213467	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 326c80f7-1d8f-4d46-ac60-ca6d21dcbbe3
Public Version Date: August 09, 2022
Public Version Number: 1
DI Record Publish Date: August 01, 2022