AccessGUDID - DEVICE: Bausch + Lomb (00757770571758)

GUDID

Device Identifier (DI) Information

Brand Name: Bausch + Lomb
Version or Model: SimplifEYE for enVista
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00757770571758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: SimplifEYE inserter for enVista Preloaded

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:	Yes
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?
47726	Intraocular lens-insertion cartridge	A sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening; the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and is removed from the injector once the IOL has been successfully inserted. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSS	Folders And Injectors, Intraocular Lens (Iol)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 66b9c897-ffb5-48db-bd9d-19bd8eeb4aff
Public Version Date: May 15, 2024
Public Version Number: 3
DI Record Publish Date: February 28, 2022