Duns Number:690409169
Device Description: Product Name: PuttyThis product has another model number, NS005P which is registered in ot Product Name: PuttyThis product has another model number, NS005P which is registered in other countries.This product has a convenience kit, NS005P-1 that only changed only in packaging materials which don't cause any change from the original functions.Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).
Catalog Number
-
Brand Name
PEAKOSIL
Version/Model Number
MSP
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
f9c6ffdc-2ec0-4a9a-b4e1-37e73deac269
Public Version Date
December 01, 2020
Public Version Number
5
DI Record Publish Date
September 21, 2017
Package DI Number
18800026400049
Quantity per Package
4
Contains DI Package
08800026400042
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 |