Micro C Medical Imaging System, Emitter Tripod - Oxos Medical, Inc.

Duns Number:080323883

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More Product Details

Catalog Number

-

Brand Name

Micro C Medical Imaging System, Emitter Tripod

Version/Model Number

ACSY-S015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

IYB

Product Code Name

Tube Mount, X-Ray, Diagnostic

Device Record Status

Public Device Record Key

41b3870d-b5a2-445b-ba22-7fdfd31ed438

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OXOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 4