BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

LIQUID OPTICS INTERFACE

DI: 05050474609778 · Model: 0180-1201 · JOHNSON & JOHNSON SURGICAL VISION, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: LIQUID OPTICS INTERFACE
Primary DI: 05050474609778
Version / Model: 0180-1201
Catalog Number: 0180-1201
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
Labeler DUNS: 010130626
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-06-08
Public Version: 4
Public Version Date: 2020-10-26
Public Version Status: Update
Public Device Record Key: a9f3f82f-80ca-4dba-9a7f-404faf6cadd7

Device Description

LIQUID OPTICS INTERFACE, SIZE 12, GEN2

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOE	Ophthalmic femtosecond laser	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61162	Ophthalmic laser system beam guide	A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050474609778	GS1

Customer Contacts

Phone: +1(877)266-4543
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: High: 55 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: High: 80 Percent (%) Relative Humidity
Type: Storage Environment Humidity
Temperature Range: High: 80 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: High: 55 Degrees Celsius