AccessGUDID - DEVICE: VISCOJECT 2.2 INJECTOR-SET (07630055220073)

GUDID

Device Identifier (DI) Information

Brand Name: VISCOJECT 2.2 INJECTOR-SET
Version or Model: LP604340
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LP604340
Company Name: Medicel AG

Primary DI Number: 07630055220073
Issuing Agency: GS1
Commercial Distribution End Date: July 17, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 487158263 *Terms of Use

Device Description: Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.

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 [?]
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: 073f4d99-ddb8-4d6c-9a9b-c27883d1dd7a
Public Version Date: December 04, 2023
Public Version Number: 4
DI Record Publish Date: October 21, 2020