25ga Dunn ILM Pick, Carbon Fiber Handle - 25ga Dunn ILM Pick, Carbon Fiber Handle - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: 25ga Dunn ILM Pick, Carbon Fiber Handle

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More Product Details

Catalog Number

-

Brand Name

25ga Dunn ILM Pick, Carbon Fiber Handle

Version/Model Number

VP3500B-25

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

HNQ

Product Code Name

Hook, Ophthalmic

Device Record Status

Public Device Record Key

711e6bc2-dd9f-4ae6-a16e-a831bc07902e

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 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