LaROE TISSUE SPREADER RETRACTOR - LaROE TISSUE SPREADER RETRACTOR MEDIUM TAPERED TIP - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: LaROE TISSUE SPREADER RETRACTOR MEDIUM TAPERED TIP

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More Product Details

Catalog Number

475-624

Brand Name

LaROE TISSUE SPREADER RETRACTOR

Version/Model Number

475-624

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

FGN

Product Code Name

RETRACTOR, NON-SELF-RETAINING

Device Record Status

Public Device Record Key

f319853e-79f7-4c12-9b7d-974687f10184

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 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