STEVENS TENOTOMY SCISSORS - STEVENS TENOTOMY SCISSORS CLASSIC CURVED SHORT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: STEVENS TENOTOMY SCISSORS CLASSIC CURVED SHORT BLADES POINTED SHARP TIPS

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More Product Details

Catalog Number

13-8815

Brand Name

STEVENS TENOTOMY SCISSORS

Version/Model Number

13-8815

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

HNF

Product Code Name

SCISSORS, OPHTHALMIC

Device Record Status

Public Device Record Key

c4f3f77e-60a8-46e6-8d02-eefdb96d974b

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 03, 2018

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