GUM SCISSORS - GUM SCISSORS CURVED SHARP BLADE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: GUM SCISSORS CURVED SHARP BLADE

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More Product Details

Catalog Number

475-153

Brand Name

GUM SCISSORS

Version/Model Number

475-153

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

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Device Record Status

Public Device Record Key

d4d08313-46d1-46d6-a85a-c0e1f6a9d030

Public Version Date

September 23, 2022

Public Version Number

3

DI Record Publish Date

September 13, 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