Duns Number:002111896
Device Description: 1 5/8" TAPE 10% CHLORIDE WET GEL60/POUCH, 600 /CASE
Catalog Number
LMC 101
Brand Name
LMC 101
Version/Model Number
6503259V
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
63bfb6c0-01a5-4998-b74b-ae245f7d2ec9
Public Version Date
June 13, 2022
Public Version Number
1
DI Record Publish Date
June 03, 2022
Package DI Number
50009336010238
Quantity per Package
10
Contains DI Package
10009336010230
Package Discontinue Date
-
Package Status
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |