THOMAS CURETTE - THOMAS CURETTE MALLEABLE BLUNT TIPS SIZE 4 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: THOMAS CURETTE MALLEABLE BLUNT TIPS SIZE 4

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More Product Details

Catalog Number

520-674

Brand Name

THOMAS CURETTE

Version/Model Number

520-674

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2020

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

HCY

Product Code Name

CURETTE, UTERINE

Device Record Status

Public Device Record Key

2cfa9207-37be-4021-b5dd-02b303234d85

Public Version Date

October 19, 2020

Public Version Number

3

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