ACE - MIRROR SIZE 3 SIMPLE STEM PLANE - ACE SURGICAL SUPPLY CO., INC.

Duns Number:042763706

Device Description: MIRROR SIZE 3 SIMPLE STEM PLANE

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More Product Details

Catalog Number

9700010

Brand Name

ACE

Version/Model Number

9700010

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

2eb5db82-0396-4ed7-bc08-a5aa98a8bb8b

Public Version Date

October 24, 2019

Public Version Number

1

DI Record Publish Date

October 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACE SURGICAL SUPPLY CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1288
2 A medical device with a moderate to high risk that requires special controls. 943
U Unclassified 6