Safco lead-free x-ray aprons - X-ray apron lead-fre adult with color blue - SAFCO DENTAL SUPPLY CO.

Duns Number:020417380

Device Description: X-ray apron lead-fre adult with color blue

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More Product Details

Catalog Number

1020382

Brand Name

Safco lead-free x-ray aprons

Version/Model Number

1020382

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

IWO

Product Code Name

Apron, protective

Device Record Status

Public Device Record Key

2f481565-edef-4a89-95ee-0d95d96ac122

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

D72310203823

Quantity per Package

3

Contains DI Package

D7231020382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SAFCO DENTAL SUPPLY CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 600
2 A medical device with a moderate to high risk that requires special controls. 23