#15- Teardrop Dissector, Straight - #15- Teardrop Dissector, Straight - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: #15- Teardrop Dissector, Straight

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More Product Details

Catalog Number

-

Brand Name

#15- Teardrop Dissector, Straight

Version/Model Number

N7115-K

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

HND

Product Code Name

Spatula, Ophthalmic

Device Record Status

Public Device Record Key

5d9af8eb-bf38-4f10-8495-24d0b5ef6794

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 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