Duns Number:007198742
Catalog Number
-
Brand Name
Endoscopic Cord 10 FT (304.8 cm)
Version/Model Number
5142708
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
K844565,K844565
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
d9222792-cd33-485c-a52b-cf00997fa238
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 12, 2016
Package DI Number
00821925010130
Quantity per Package
12
Contains DI Package
00821925037762
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |