Zero Gravity - Radiation Protection System Upgrade from Floor to - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: Radiation Protection System Upgrade from Floor to Hinged Swing Arm Design; ZGM-6-5H Upgrad Radiation Protection System Upgrade from Floor to Hinged Swing Arm Design; ZGM-6-5H Upgrade to ZGHH-HSA

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More Product Details

Catalog Number

ZGHH-HAS

Brand Name

Zero Gravity

Version/Model Number

ZGHH-HAS

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

-

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

EAJ

Product Code Name

Apron, Leaded

Device Record Status

Public Device Record Key

c923f079-8b65-4dd3-a7df-df220e154ec0

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TIDI PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 2255