Grasping Forceps - Grasping Forceps With Reservoir Sharp Double - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Grasping Forceps With Reservoir Sharp Double Action Jaw For 3 Millimeters Diameter Tube Sh Grasping Forceps With Reservoir Sharp Double Action Jaw For 3 Millimeters Diameter Tube Shaft 180 Millimeters

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More Product Details

Catalog Number

-

Brand Name

Grasping Forceps

Version/Model Number

2901-205S

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

K102921

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

86a74d61-6796-48c0-b9c2-d0ea7d40fb97

Public Version Date

April 16, 2021

Public Version Number

1

DI Record Publish Date

April 08, 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