Duns Number:002348191
Device Description: COAGULATION SUCTION TUBE, DISPOSABLE, WITH STYLET, 8", 10/BX
Catalog Number
809610
Brand Name
WECK
Version/Model Number
IPN010077
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
dfa49dd3-9dae-4acb-b02c-902d90b43b86
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
44026704601569
Quantity per Package
1
Contains DI Package
24026704601565
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 |