FlowerRope - FlowerRope - TENSYN MEDICAL, INC.

Duns Number:081514431

Device Description: FlowerRope

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


More Product Details

Catalog Number

-

Brand Name

FlowerRope

Version/Model Number

DLF 001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2021

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

HTN

Product Code Name

Washer, Bolt Nut

Device Record Status

Public Device Record Key

0b98056f-f14f-4330-8795-504136f8e9a1

Public Version Date

October 06, 2022

Public Version Number

2

DI Record Publish Date

April 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

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