GEN2 - Approximator Clamp, frame, 1.0-2.25mm, B - SURGIX MEDICAL LLC

Duns Number:080402644

Device Description: Approximator Clamp, frame, 1.0-2.25mm, B

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More Product Details

Catalog Number

G2N99395

Brand Name

GEN2

Version/Model Number

G2N99395

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

K120492

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

046cef15-7dbf-425d-8aed-290e8ebce624

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