AccessGUDID - DEVICE: Inverter Vitrectomy System For Leica Type Microscopes (00630238111607)

GUDID

Device Identifier (DI) Information

Brand Name: Inverter Vitrectomy System For Leica Type Microscopes
Version or Model: OIVS2L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULAR INSTRUMENTS, INC.

Primary DI Number: 00630238111607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046212387 *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):	No
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?
58037	Vitrectomy contact lens, reusable	A non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), It is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a reusable device that must be sterilized before application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 3bf2ffd9-b326-4048-8421-b235c68398cc
Public Version Date: June 19, 2019
Public Version Number: 1
DI Record Publish Date: June 11, 2019