Regard™ - RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Duns Number:134472476

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


More Product Details

Catalog Number

-

Brand Name

Regard™

Version/Model Number

236170

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)

-

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

GAB

Product Code Name

Needle, Suturing, Disposable

Device Record Status

Public Device Record Key

2f4c7e96-d9a8-48aa-a760-e264216dd274

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

10326053102650

Quantity per Package

96

Contains DI Package

30326053102654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RESOURCE OPTIMIZATION & INNOVATION, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 558