Stephens Instruments - Shocket Scleral Depressor, Single Use, 10/Box - KRISHNA IMPORTS INC

Duns Number:081853285

Device Description: Shocket Scleral Depressor, Single Use, 10/Box

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More Product Details

Catalog Number

SSD4 1231

Brand Name

Stephens Instruments

Version/Model Number

SSD4 1231

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

HNX

Product Code Name

Depressor, orbital

Device Record Status

Public Device Record Key

0bfe9d33-b4a0-4818-a70a-d16206f50dae

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2020

Additional Identifiers

Package DI Number

00810799039408

Quantity per Package

10

Contains DI Package

00810799039415

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