FREER ELEVATOR - FREER ELEVATOR DOUBLE NARROW ENDED SHARP/BLUNT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: FREER ELEVATOR DOUBLE NARROW ENDED SHARP/BLUNT TIPS LARGE SQUARE HANDLE

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More Product Details

Catalog Number

1100-798G

Brand Name

FREER ELEVATOR

Version/Model Number

1100-798G

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

GEG

Product Code Name

ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

77576448-6a7c-445b-8036-52333399ecee

Public Version Date

May 23, 2019

Public Version Number

4

DI Record Publish Date

September 14, 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