Duns Number:105932508
Device Description: Specula, Disposable, 2.5mm (100 per pack, gray) for PICCOLIGHT®
Catalog Number
-
Brand Name
KaWe
Version/Model Number
61-910-100
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FXG
Product Code Name
Specula Accessories
Public Device Record Key
51f6eace-8d0b-4e1e-8ed7-182d4510e35f
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |