Duns Number:054875224
Device Description: Multi-Unit Verification Cylinder w/ .050 ScrewKit contains:1 Verification Cylinder for Mul Multi-Unit Verification Cylinder w/ .050 ScrewKit contains:1 Verification Cylinder for Multi-unit (00842092162286)1 Multi-Unit Titanium Screw (00842092165287)
Catalog Number
9003730
Brand Name
Implant Prosthetics
Version/Model Number
9003730
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
K183518,K183518,K183518,K183518,K183518
Product Code
NHA
Product Code Name
Abutment, implant, dental, endosseous
Public Device Record Key
d35b096c-8525-478a-b997-051d4c5cebc4
Public Version Date
October 19, 2022
Public Version Number
2
DI Record Publish Date
October 04, 2022
Package DI Number
00842092175644
Quantity per Package
10
Contains DI Package
00842092165317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 958 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1846 |