Digital Therapist - SWORD HEALTH, S.A.

Duns Number:338007105

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More Product Details

Catalog Number

-

Brand Name

Digital Therapist

Version/Model Number

SWORDPhoenix-13

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

-

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

ISD

Product Code Name

Exerciser, Measuring

Device Record Status

Public Device Record Key

969b82be-bfa4-4b68-a353-d94724484ec5

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWORD HEALTH, S.A." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11