Attachable delivery unit (SL130) - The attachable delivery unit is attached to the - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter calle The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter called Zeiss SL 130) to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 to comprise a photocoagulation system.The photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit.

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More Product Details

Catalog Number

-

Brand Name

Attachable delivery unit (SL130)

Version/Model Number

17464-0000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

c8e3d0c3-d362-4a85-8b4a-32d54cd97abe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIDEK CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 73
3 A medical device with high risk that requires premarket approval 5