CONVERSE HAND RETRACTOR - CONVERSE HAND RETRACTOR WITH FIBER OPTIC LIGHT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: CONVERSE HAND RETRACTOR WITH FIBER OPTIC LIGHT GUIDE DOUBLE ENDED STRAIGHT/CURVED BLADES # CONVERSE HAND RETRACTOR WITH FIBER OPTIC LIGHT GUIDE DOUBLE ENDED STRAIGHT/CURVED BLADES #1

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More Product Details

Catalog Number

205-907L

Brand Name

CONVERSE HAND RETRACTOR

Version/Model Number

205-907L

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

FDG

Product Code Name

RETRACTOR, FIBEROPTIC

Device Record Status

Public Device Record Key

619bff21-0a68-4281-9214-31236c1c32e5

Public Version Date

October 19, 2018

Public Version Number

1

DI Record Publish Date

September 18, 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