PORTRAY - Coupler Ring w/ Magnets - Surround Medical Systems

Duns Number:080829354

Device Description: Coupler Ring w/ Magnets

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More Product Details

Catalog Number

16-110031

Brand Name

PORTRAY

Version/Model Number

DH.B0.00

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)

-

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

EGZ

Product Code Name

Holder, Film, X-Ray

Device Record Status

Public Device Record Key

b34b4e83-a702-40ba-a935-45c5d2eb6efd

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURROUND MEDICAL SYSTEMS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 2