Duns Number:690409169
Device Description: Product Name: PEAKOSIL One-Time PuttyThis product is a convenience kit of Putty(MSP).This Product Name: PEAKOSIL One-Time PuttyThis product is a convenience kit of Putty(MSP).This product changed only in packaging materials from Putty.These changes don't cause any change from the original functions of Putty.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
NS005P-1
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
4117644e-223b-4bd7-9e40-cd6ebfaa441f
Public Version Date
June 30, 2021
Public Version Number
4
DI Record Publish Date
January 03, 2020
Package DI Number
18800026400124
Quantity per Package
10
Contains DI Package
08800026400127
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 |