RAMIREZ ENDOSCOPIC FOREHEAD PERIOSTEAL MALLEABLE SCISSORS - RAMIREZ ENDOSCOPIC FOREHEAD PERIOSTEAL MALLEABLE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: RAMIREZ ENDOSCOPIC FOREHEAD PERIOSTEAL MALLEABLE SCISSORS CURVED SHAFT VERTICAL

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More Product Details

Catalog Number

-

Brand Name

RAMIREZ ENDOSCOPIC FOREHEAD PERIOSTEAL MALLEABLE SCISSORS

Version/Model Number

2800-0001

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

GZX

Product Code Name

Instrument, Microsurgical

Device Record Status

Public Device Record Key

14f00adf-0c35-4fc6-982d-8c49285f93a2

Public Version Date

September 23, 2022

Public Version Number

3

DI Record Publish Date

September 07, 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