Duns Number:622467348
Device Description: 20GA Wide Angle Light Pipe - 297 Connector
Catalog Number
-
Brand Name
20GA Wide Angle Light Pipe - 297 Connector
Version/Model Number
PD102.09
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
HJM
Product Code Name
Transilluminator, ac-powered
Public Device Record Key
6d565ae5-22a9-4306-83e8-3770a34324ad
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
May 06, 2016
Package DI Number
10632307001199
Quantity per Package
5
Contains DI Package
00632307001192
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 |