AccessGUDID - DEVICE: bioli™ IOL Delivery System (10814899027126)

GUDID

Device Identifier (DI) Information

Brand Name: bioli™ IOL Delivery System
Version or Model: BIOLI-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AST PRODUCTS, INC.

Primary DI Number: 10814899027126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 611655440 *Terms of Use

Device Description: The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.

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?
47725	Manual intraocular lens injector, single-use	A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. 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 [?]
K200057	000

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: 5950d6ca-4b70-4fb2-838c-432ef304f2bd
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: December 07, 2020