Duns Number:690409169
Device Description: Product Name:PEAKOSIL Bite Regular Set.This product has another model number, NS011C which Product Name:PEAKOSIL Bite Regular Set.This product has another model number, NS011C which is registered in other countries.
Catalog Number
-
Brand Name
PEAKOSIL
Version/Model Number
MSBC
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,K152180
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
2b1b439c-1748-448e-b12c-b258c6a84eb3
Public Version Date
June 30, 2021
Public Version Number
3
DI Record Publish Date
January 07, 2019
Package DI Number
18800026400032
Quantity per Package
4
Contains DI Package
08800026400035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |