Duns Number:002348191
Device Description: COAGULATION SUCTION TUBE, DISPOSABLE, WITH STYLET, 8 INCHES, 10/BOX
Catalog Number
809610
Brand Name
WECK
Version/Model Number
IPN039271
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"
-
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
K881413,K881413,K881413,K881413
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
dfbc9791-aa7e-496e-9eb2-68aab6cec41a
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
June 03, 2019
Package DI Number
24026704662153
Quantity per Package
10
Contains DI Package
14026704662156
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |