PTR Robots - Hand controller for PTR Robot - Blue Ocean Robotics ApS

Duns Number:305391168

Device Description: Hand controller for PTR Robot

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More Product Details

Catalog Number

200944

Brand Name

PTR Robots

Version/Model Number

G1

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

FSA

Product Code Name

Lift, Patient, Non-Ac-Powered

Device Record Status

Public Device Record Key

25558d5a-c8df-45dd-a1f8-c61712ec514f

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLUE OCEAN ROBOTICS APS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4