BENNETT RETRACTOR - BENNETT RETRACTOR CROSS ACTION SHARP SELF - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BENNETT RETRACTOR CROSS ACTION SHARP SELF RETAINING TIPS

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More Product Details

Catalog Number

1103-862

Brand Name

BENNETT RETRACTOR

Version/Model Number

1103-862

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"

Yes

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

7b14728b-a73f-4fd5-9e94-1ef0e21dad67

Public Version Date

September 19, 2019

Public Version Number

2

DI Record Publish Date

June 12, 2019

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