BABY GOLD CUT HERCULES PIN CUTTER - BABY GOLD CUT HERCULES PIN CUTTER EXCHANGEABLE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BABY GOLD CUT HERCULES PIN CUTTER EXCHANGEABLE RIGHT-HANDED TUNGSTEN CARBIDE BLADES/RUBBER BABY GOLD CUT HERCULES PIN CUTTER EXCHANGEABLE RIGHT-HANDED TUNGSTEN CARBIDE BLADES/RUBBER JAWS

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


More Product Details

Catalog Number

355-186

Brand Name

BABY GOLD CUT HERCULES PIN CUTTER

Version/Model Number

355-186

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

HXZ

Product Code Name

CUTTER, WIRE

Device Record Status

Public Device Record Key

ac671318-e57c-4b7f-b298-4eb4da9e1085

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 12, 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