iSert Intraocular Lens - HOYA MEDICAL SINGAPORE PTE. LTD.

Duns Number:894831895

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More Product Details

Catalog Number

-

Brand Name

iSert Intraocular Lens

Version/Model Number

250 (clear), +25.00D

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

Yes

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

HQL

Product Code Name

Intraocular Lens

Device Record Status

Public Device Record Key

e8cef01a-eafa-453a-a97c-c5c9138d9706

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOYA MEDICAL SINGAPORE PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 622