Metzenbaum Scissors - Metzenbaum Preparation Scissors Straight Double - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Metzenbaum Preparation Scissors Straight Double Action Jaws Tube Shaft

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More Product Details

Catalog Number

-

Brand Name

Metzenbaum Scissors

Version/Model Number

2901-301L

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

K102921

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

137135ab-e720-4a61-85bb-de8cbc048e6a

Public Version Date

December 06, 2021

Public Version Number

1

DI Record Publish Date

November 26, 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