Henry Schein - Maxi-Gard X-Ray Lead Collar - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Maxi-Gard X-Ray Lead Collar

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


More Product Details

Catalog Number

5701375

Brand Name

Henry Schein

Version/Model Number

5701375

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

IWO

Product Code Name

Apron, protective

Device Record Status

Public Device Record Key

7382fbe5-785f-41d4-baaf-6021714f63c1

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34