BIOPSY GRASPING FORCEPS - BIOPSY GRASPING FORCEPS WITH OVERLOAD CONE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BIOPSY GRASPING FORCEPS WITH OVERLOAD CONE STRAIGHT TIP

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More Product Details

Catalog Number

1271-107

Brand Name

BIOPSY GRASPING FORCEPS

Version/Model Number

1271-107

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Device Record Status

Public Device Record Key

4ce36ad4-456f-4a36-8f68-7027cc654688

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

March 25, 2019

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