UNIVERSAL EXTRACTION FORCEPS - UNIVERSAL EXTRACTION FORCEPS #150S PEDIATRIC - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: UNIVERSAL EXTRACTION FORCEPS #150S PEDIATRIC UPPER PRIMARY TEETH/ROOTS

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More Product Details

Catalog Number

1103-351U

Brand Name

UNIVERSAL EXTRACTION FORCEPS

Version/Model Number

1103-351U

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

EMG

Product Code Name

FORCEPS, TOOTH EXTRACTOR, SURGICAL

Device Record Status

Public Device Record Key

9396e7a6-ec24-4373-99a9-211fd4715239

Public Version Date

September 26, 2019

Public Version Number

5

DI Record Publish Date

March 07, 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