Frontal Sinus Giraffe Forceps - Frontal Sinus Giraffe Forceps Double Action Cup - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Frontal Sinus Giraffe Forceps Double Action Cup 70 Degrees Horizontal

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More Product Details

Catalog Number

-

Brand Name

Frontal Sinus Giraffe Forceps

Version/Model Number

468-323

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

KAE

Product Code Name

FORCEPS, ENT

Device Record Status

Public Device Record Key

2ca78b45-e5e9-451d-9c76-50cf2b3786db

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

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