ACE - * OPEN TRAY IMP COPING 3.5&4HD CONICAL ABUT 4.5CW - ACE SURGICAL SUPPLY CO., INC.

Duns Number:042763706

Device Description: * OPEN TRAY IMP COPING 3.5&4HD CONICAL ABUT 4.5CW W/19522002

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More Product Details

Catalog Number

03609031

Brand Name

ACE

Version/Model Number

03609031

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

Yes

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

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

dfea2d7b-8713-4be9-91ff-ba997095a00c

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 19, 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