KNEE CRUTCHES WITH FOOT SUPPORT NO CLAMPS - KNEE CRUTCHES WITH FOOT SUPPORT NO CLAMPS - SKYTRON LLC

Duns Number:078375583

Device Description: KNEE CRUTCHES WITH FOOT SUPPORT NO CLAMPS

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

KNEE CRUTCHES WITH FOOT SUPPORT NO CLAMPS

Version/Model Number

4-010-03-1

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)

Yes

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

LWG

Product Code Name

Surgical Table Cushion

Device Record Status

Public Device Record Key

54bf133f-979b-4741-ac4a-f029f442c90c

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKYTRON LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 747
2 A medical device with a moderate to high risk that requires special controls. 265