Duns Number:690409169
Device Description: Product Name : Start KitThis original PEAKOSIL Start Kit(NSSK) is a kitincluding PEAKOSIL Product Name : Start KitThis original PEAKOSIL Start Kit(NSSK) is a kitincluding PEAKOSIL Light Body 2 EA, PEAKOSIL Putty 1 EA, Yellow Mix Tip 6 EA & Intra Oral Tip 6 EA.The contents of this kit are all registered in FDA.
Catalog Number
-
Brand Name
PEAKOSIL
Version/Model Number
NSSK
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152180,K152180
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
8d743fc1-b425-4017-9e77-3e4aeb48c146
Public Version Date
January 03, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2017
Package DI Number
18800026400070
Quantity per Package
25
Contains DI Package
08800026400073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |