Forward - Field Minor Surgery Kit - SYNCHRONIS MEDICAL, LLC

Duns Number:080160207

Device Description: Field Minor Surgery Kit

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More Product Details

Catalog Number

4818-32004

Brand Name

Forward

Version/Model Number

4818-32004

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

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

2656af62-df7d-43c9-b2ad-9bcfe9815026

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

August 13, 2020

Additional Identifiers

Package DI Number

00850015884023

Quantity per Package

12

Contains DI Package

00860000925334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SYNCHRONIS MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 12