Cravat/Triangular Bandage, Box 50 - Sling, Arm - Chinook Medical Gear

Duns Number:621904622

Device Description: Sling, Arm

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More Product Details

Catalog Number

05001-50

Brand Name

Cravat/Triangular Bandage, Box 50

Version/Model Number

05001-50

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

Yes

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

ILI

Product Code Name

Sling, Arm

Device Record Status

Public Device Record Key

6ca732bc-8c3e-43ae-aa34-bf735eaa6a87

Public Version Date

May 26, 2020

Public Version Number

1

DI Record Publish Date

May 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHINOOK MEDICAL GEAR" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 30