Duns Number:622467348
Device Description: 25GA Wide Angle Light Pipe - Universal
Catalog Number
-
Brand Name
25GA Wide Angle Light Pipe - Universal
Version/Model Number
PD125.14
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
K980025,K980025
Product Code
MPA
Product Code Name
Endoilluminator
Public Device Record Key
3bb9d265-ac1e-4b2f-9fbb-1398f72b9e9c
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
May 06, 2016
Package DI Number
10632307001397
Quantity per Package
5
Contains DI Package
00632307001390
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 |