Stephens Instruments - 2.8mm Angle Slit Knife - KRISHNA IMPORTS INC

Duns Number:081853285

Device Description: 2.8mm Angle Slit Knife

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More Product Details

Catalog Number

R-5516

Brand Name

Stephens Instruments

Version/Model Number

R-5516

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)

-

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

13016f1d-9851-43cc-8777-0b0efe4f9b05

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Additional Identifiers

Package DI Number

00810799030290

Quantity per Package

6

Contains DI Package

00810799030306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"KRISHNA IMPORTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 995
U Unclassified 24