Ball Probe - Spetzer Type Angled Ball Probe 90 Degree - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Spetzer Type Angled Ball Probe 90 Degree

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


More Product Details

Catalog Number

7793-21

Brand Name

Ball Probe

Version/Model Number

7793-21

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

FZS

Product Code Name

Curette, Surgical, General Use

Device Record Status

Public Device Record Key

f3e47dfe-e66b-4e1a-b3a3-89b91679675b

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOROS U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2597
2 A medical device with a moderate to high risk that requires special controls. 416