GEN2 - Round Handle Forceps, 8mm dia., curved tip, 0.3mm - SURGIX MEDICAL LLC

Duns Number:080402644

Device Description: Round Handle Forceps, 8mm dia., curved tip, 0.3mm dia., w/platform, w/counterweight, 6" (1

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

G2N99394

Brand Name

GEN2

Version/Model Number

G2N99394

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

EMD

Product Code Name

Hemostat, Surgical

Device Record Status

Public Device Record Key

99879b50-9ccc-495c-9b12-67e9314bba98

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGIX MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 738
2 A medical device with a moderate to high risk that requires special controls. 1804