Tortoise™ Turning & positioning system - Large Tortoise - Mölnlycke Health Care AB

Duns Number:631770658

Device Description: Large Tortoise

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More Product Details

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

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

FMR

Product Code Name

DEVICE, TRANSFER, PATIENT, MANUAL

Device Record Status

Public Device Record Key

2f7e9078-947a-4035-9970-66dccd147c8f

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Additional Identifiers

Package DI Number

07323190231669

Quantity per Package

1

Contains DI Package

07323190234622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MÖLNLYCKE HEALTH CARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 212
2 A medical device with a moderate to high risk that requires special controls. 15
U Unclassified 18