23ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft - KATALYST SURGICAL LLC

Duns Number:007883297

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More Product Details

Catalog Number

-

Brand Name

23ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft

Version/Model Number

6850C-M32

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2020

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

HNF

Product Code Name

Scissors, Ophthalmic

Device Record Status

Public Device Record Key

3fc9161a-1633-4e11-8061-7de273dbb2fe

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATALYST SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1640
2 A medical device with a moderate to high risk that requires special controls. 288