PHOTOGRAPHIC STAINLESS STEEL MIRRORS - PHOTOGRAPHIC STAINLESS STEEL MIRRORS (SHAPE G) - ORTHO ORGANIZERS, INC.

Duns Number:062165188

Device Description: PHOTOGRAPHIC STAINLESS STEEL MIRRORS (SHAPE G)

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More Product Details

Catalog Number

-

Brand Name

PHOTOGRAPHIC STAINLESS STEEL MIRRORS

Version/Model Number

631-090G

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)

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

EAX

Product Code Name

MIRROR, MOUTH

Device Record Status

Public Device Record Key

5cc7f6a1-9838-4347-889e-8fdd182f917b

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

September 08, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO ORGANIZERS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8511
2 A medical device with a moderate to high risk that requires special controls. 1527