CHONDRO PICK - CHONDRO PICK ANGLED TIP SILICONE HANDLE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: CHONDRO PICK ANGLED TIP SILICONE HANDLE

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More Product Details

Catalog Number

1271-318

Brand Name

CHONDRO PICK

Version/Model Number

1271-318

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

HWJ

Product Code Name

AWL

Device Record Status

Public Device Record Key

f69ef69a-0090-434b-915a-c8dc7eb762d3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 10, 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