Stephens Instruments - Barraquer Speculum, Solid, Adult, Temporal, 15mm - KRISHNA IMPORTS INC

Duns Number:081853285

Device Description: Barraquer Speculum, Solid, Adult, Temporal, 15mm

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More Product Details

Catalog Number

S1-1013

Brand Name

Stephens Instruments

Version/Model Number

S1-1013

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

HNC

Product Code Name

Specula, ophthalmic

Device Record Status

Public Device Record Key

94373b91-5d1e-4a66-b3f4-be39524d0283

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