Debakey Forceps - Debakey Forceps Flat Handle 2 x 3 Teeth Delicate - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Debakey Forceps Flat Handle 2 x 3 Teeth Delicate Tip Titanium

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More Product Details

Catalog Number

-

Brand Name

Debakey Forceps

Version/Model Number

2600-341

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

HTD

Product Code Name

FORCEPS

Device Record Status

Public Device Record Key

6865d8dc-ff0d-497b-bde3-6a9292ced7fe

Public Version Date

December 15, 2021

Public Version Number

1

DI Record Publish Date

December 07, 2021

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