DALTON MANUAL WHEELCHAIR RECLINER - WHEELCHAIR, MANUAL, 20" W/LEGREST, RECLINER, WT - DALTON MEDICAL CORPORATION

Duns Number:874709348

Device Description: WHEELCHAIR, MANUAL, 20" W/LEGREST, RECLINER, WT LIMIT 310 LBS

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More Product Details

Catalog Number

-

Brand Name

DALTON MANUAL WHEELCHAIR RECLINER

Version/Model Number

K477A20L15

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

IOR

Product Code Name

Wheelchair, Mechanical

Device Record Status

Public Device Record Key

341757ec-e18d-477a-98b5-c86fb38a3b84

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DALTON MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 57