4WEB Medical - 4web Medical

Duns Number:021323706

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More Product Details

Catalog Number

ASTS-SA-SM0614-SR

Brand Name

4WEB Medical

Version/Model Number

ASTS-SA-SM0614-SR

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

cf7b176f-f9a6-420b-9495-861d71e3ddca

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

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