Duns Number:305524696
Device Description: Seldinger PTFE-coated guidewire/J-Tip/stiff fixed core, length 80 cm
Catalog Number
AE1138
Brand Name
Porges Coloplast
Version/Model Number
AE1138
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
OCY
Product Code Name
Endoscopic guidewire, gastroenterology-urology
Public Device Record Key
5eb7d2e1-bb58-4506-9c5f-bc5d12effec6
Public Version Date
July 08, 2019
Public Version Number
1
DI Record Publish Date
June 30, 2019
Package DI Number
03600040184004
Quantity per Package
5
Contains DI Package
03600040183991
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |