Duns Number:196603781
Device Description: BIPOLAR CORD 12FT DISP 10/BOX
Catalog Number
S2070 C
Brand Name
Bausch + Lomb
Version/Model Number
S2070 C
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
459d6423-eb1c-4437-a911-19a989d540c4
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
Package DI Number
20757770458039
Quantity per Package
10
Contains DI Package
00757770458035
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 | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 134 |
| 3 | A medical device with high risk that requires premarket approval | 3348 |
| U | Unclassified | 1 |