Gemcision™ Keratome Lancet, Super Sharp, 2.5mm Width/Box of 5 - Gemcision™ Keratome Lancet, Super Sharp, 2.5mm - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: Gemcision™ Keratome Lancet, Super Sharp, 2.5mm Width/Box of 5

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More Product Details

Catalog Number

-

Brand Name

Gemcision™ Keratome Lancet, Super Sharp, 2.5mm Width/Box of 5

Version/Model Number

7920-K25b

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

HNN

Product Code Name

Knife, Ophthalmic

Device Record Status

Public Device Record Key

c9663cae-5b20-4ca5-a714-fa7d06c1ce2a

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

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