ReNew - Ratcheted Handpiece, 34cm, Reusable - MICROLINE SURGICAL, INC.

Duns Number:184080570

Device Description: Ratcheted Handpiece, 34cm, Reusable

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More Product Details

Catalog Number

3914R

Brand Name

ReNew

Version/Model Number

3914R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2018

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

fb7de686-0ade-4a6e-9af9-18cfe216341b

Public Version Date

July 13, 2021

Public Version Number

3

DI Record Publish Date

November 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROLINE SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 84