Duns Number:083171244
Device Description: Extended Tip Applicator 8cm 5 pack
Catalog Number
205108
Brand Name
Extended Tip Applicator
Version/Model Number
205108
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"
Yes
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
K091315,K091315
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
c6ebef11-b2bb-4f03-88b0-74d865568c00
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
December 29, 2016
Package DI Number
30381780000147
Quantity per Package
5
Contains DI Package
10381780000143
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |