Krayenbuehl Nerve Hook - Krayenbuehl Nerve Hook Sharp Tip - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Krayenbuehl Nerve Hook Sharp Tip

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More Product Details

Catalog Number

-

Brand Name

Krayenbuehl Nerve Hook

Version/Model Number

400-445C

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

GDG

Product Code Name

HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

72e3a3c8-6586-476a-b0d5-3f456b61e5d6

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

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