CARRYING CASE - CARRYING CASE FOR BINOCULAR LOUPE OPTICS/S-FRAME - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: CARRYING CASE FOR BINOCULAR LOUPE OPTICS/S-FRAME SETS

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More Product Details

Catalog Number

C-000.32.552

Brand Name

CARRYING CASE

Version/Model Number

C-000.32.552

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)

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

FSP

Product Code Name

LOUPE, DIAGNOSTIC/SURGICAL

Device Record Status

Public Device Record Key

299ad03e-6aad-45b6-b178-8acb8bd6092e

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414