GOLDMAN-FOX SCISSORS - GOLDMAN-FOX SCISSORS TENOTOMY TIP POWER CUT GOLD - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: GOLDMAN-FOX SCISSORS TENOTOMY TIP POWER CUT GOLD CURVED QUANTUM

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More Product Details

Catalog Number

1200-405Q

Brand Name

GOLDMAN-FOX SCISSORS

Version/Model Number

1200-405Q

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

KBD

Product Code Name

Scissors, Nasal

Device Record Status

Public Device Record Key

123c2140-aa01-4910-9081-822848c63456

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

May 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