25ga Subretinal Cannula - 25ga Subretinal Cannula, box of 5 - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: 25ga Subretinal Cannula, box of 5

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More Product Details

Catalog Number

-

Brand Name

25ga Subretinal Cannula

Version/Model Number

DVC1510-25

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

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

HMX

Product Code Name

Cannula, Ophthalmic

Device Record Status

Public Device Record Key

d0dad3f3-150f-4cca-8e07-fc9e9e9f50d7

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 14, 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