MaxLight® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Purple) - OCULAR INSTRUMENTS, INC.

Duns Number:046212387

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More Product Details

Catalog Number

-

Brand Name

MaxLight® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Purple)

Version/Model Number

OI-STD-LR/P

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)

-

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

HJL

Product Code Name

Lens, Condensing, Diagnostic

Device Record Status

Public Device Record Key

98de90ca-bc07-4ca7-9064-18cde7ca120d

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

June 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCULAR INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 47