Duns Number:042763706
Device Description: TITANIUM MICRO MESH 7X14MM .2MM THICK CP GRADE 1 NON STERILE
Catalog Number
0039434
Brand Name
ACE
Version/Model Number
0039434
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K951392
Product Code
OAT
Product Code Name
Implant, Endosseous, Orthodontic
Public Device Record Key
4bc25cd7-4624-4602-8978-7e10ecbf3748
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
December 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |