Stephens Instruments - Kelman Lens Holding & Manipulating Forceps - KRISHNA IMPORTS INC

Duns Number:081853285

Device Description: Kelman Lens Holding & Manipulating Forceps

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More Product Details

Catalog Number

S5-1742

Brand Name

Stephens Instruments

Version/Model Number

S5-1742

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

HNR

Product Code Name

Forceps, ophthalmic

Device Record Status

Public Device Record Key

a44fbcf1-568f-4929-b225-065d4fb6c0bd

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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