SMALL JOINT ARTHROSCOPIC CANNULA - SMALL JOINT ARTHROSCOPIC CANNULA - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: SMALL JOINT ARTHROSCOPIC CANNULA

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SC95-0422

Brand Name

SMALL JOINT ARTHROSCOPIC CANNULA

Version/Model Number

SC95-0422

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"

Yes

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

df2523fb-9c34-4184-a4a7-bfe6cf5983b3

Public Version Date

February 04, 2019

Public Version Number

1

DI Record Publish Date

January 03, 2019

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