TEBBETTS SUCTION WOUND RETRACTOR - TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED TOOTHED STRAIGHT EDGE

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More Product Details

Catalog Number

-

Brand Name

TEBBETTS SUCTION WOUND RETRACTOR

Version/Model Number

46933-04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2018

Issuing Agency

In HIBCC

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)

-

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

b66cdd89-e357-4f5e-9985-2b624a499725

Public Version Date

September 24, 2018

Public Version Number

6

DI Record Publish Date

August 19, 2016

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