Duns Number:787855907
Device Description: Laser Resistant Wand with Sponge Guard
Catalog Number
WLRT410
Brand Name
Buffalo Filter
Version/Model Number
WLRT410
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
1a321b3a-623f-44a4-93fb-fdf13fc7bbf5
Public Version Date
April 22, 2022
Public Version Number
4
DI Record Publish Date
September 30, 2016
Package DI Number
10851136002508
Quantity per Package
10
Contains DI Package
00851136002501
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |