AccessGUDID - DEVICE: EVA, combined machine (08717872029672)

GUDID

Device Identifier (DI) Information

Brand Name: EVA, combined machine
Version or Model: 8000.COM01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8000.COM01
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872029672
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142877	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: 86bef96b-5535-4192-aa79-b5835e22f907
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 23, 2018