DDP Extraction Forceps - Tooth Extraction Forceps 1A - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Tooth Extraction Forceps 1A

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More Product Details

Catalog Number

Forceps (1-A)

Brand Name

DDP Extraction Forceps

Version/Model Number

Forceps (1-A)

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

EMG

Product Code Name

Forceps, Tooth Extractor, Surgical

Device Record Status

Public Device Record Key

468d4f9e-2e97-4f5b-99d8-74f3e542f1ce

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNCOAST DENTAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 405
2 A medical device with a moderate to high risk that requires special controls. 536