ACE Surgical Supply - ACE 0.5 GRAM CALCIUM SULFATE HEMIHYDRATE KIT - ACE SURGICAL SUPPLY CO., INC.

Duns Number:042763706

Device Description: ACE 0.5 GRAM CALCIUM SULFATE HEMIHYDRATE KIT

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

5052002

Brand Name

ACE Surgical Supply

Version/Model Number

5052002

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

LYC

Product Code Name

Bone grafting material, synthetic

Device Record Status

Public Device Record Key

4a79ae0f-dc52-4385-87a3-ed5f2c2c2166

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

March 02, 2017

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