Catalog Number

-

Brand Name

Tortoise™ Turning & positioning system

Version/Model Number

1400801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FMR

Product Code Name

DEVICE, TRANSFER, PATIENT, MANUAL

Public Device Record Key

e75d378e-9e9c-4f6e-ba3a-24ed516a51df

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07323190277674

Quantity per Package

1

Contains DI Package

07323190277681

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE