Latina 5 Bar Indexing SLT Gonio Laser Lens - OCULAR INSTRUMENTS, INC.

Duns Number:046212387

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More Product Details

Catalog Number

-

Brand Name

Latina 5 Bar Indexing SLT Gonio Laser Lens

Version/Model Number

OL5SLT-IR

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

HKS

Product Code Name

Prism, Gonioscopic

Device Record Status

Public Device Record Key

8d23cc8b-0e73-4773-bff8-007d438eb456

Public Version Date

March 16, 2021

Public Version Number

2

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