Duns Number:622467348
Device Description: 23GA Sheilded Wide Angle Light Pipe - Universal
Catalog Number
-
Brand Name
23GA Sheilded Wide Angle Light Pipe - Universal
Version/Model Number
PD123.14S
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
-
Product Code
MPA
Product Code Name
Endoilluminator
Public Device Record Key
2186e1f2-3b1e-4204-be3e-62d585761fc2
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
May 06, 2016
Package DI Number
10632307001373
Quantity per Package
5
Contains DI Package
00632307001376
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 | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |