4WEB Medical - 4web Medical

Duns Number:021323706

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More Product Details

Catalog Number

ASCR-5523-SD-SP

Brand Name

4WEB Medical

Version/Model Number

ASCR-5523-SD-SP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

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

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Device Record Status

Public Device Record Key

6478e863-0355-4a1b-a5a8-265760a5c5ae

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"4WEB MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1166
2 A medical device with a moderate to high risk that requires special controls. 1198