BACKBITER PUNCH BITE - BACKBITER PUNCH STRAIGHT BITE QUICK CLICK INSERT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BACKBITER PUNCH STRAIGHT BITE QUICK CLICK INSERT

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More Product Details

Catalog Number

1272-527SIN

Brand Name

BACKBITER PUNCH BITE

Version/Model Number

1272-527SIN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2020

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

LRY

Product Code Name

PUNCH, SURGICAL

Device Record Status

Public Device Record Key

c7c1d031-dd3b-47eb-a221-7755fc9e3a90

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

September 11, 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