N/A - INFINI MFR TIP A-49 1 ea(MFR 49 Tip) - Lutronic Corporation

Duns Number:688282516

Device Description: INFINI MFR TIP A-49 1 ea(MFR 49 Tip)

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

TIP A-49 1 ea

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

Yes

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

368e2e9c-e69f-486f-bea8-1652c59f2762

Public Version Date

July 26, 2021

Public Version Number

4

DI Record Publish Date

November 18, 2016

Additional Identifiers

Package DI Number

8809447651774

Quantity per Package

1

Contains DI Package

08809447651781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"LUTRONIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 145