Stevens Saberback Tenotomy Scissors - Stevens Saberback Tenotomy Scissors Pointed Tips - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Stevens Saberback Tenotomy Scissors Pointed Tips Tungsten Carbide Power Cut Curved Quantum

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More Product Details

Catalog Number

-

Brand Name

Stevens Saberback Tenotomy Scissors

Version/Model Number

2400-367Q

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

HRR

Product Code Name

SCISSORS, ORTHOPEDIC, SURGICAL

Device Record Status

Public Device Record Key

5cf9a75f-1c6e-4dfe-bd54-bda39aa07507

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 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