Duns Number:006261481
Device Description: CATHETER LA5AL105 LA 5F 5PK 100 AL10
Catalog Number
-
Brand Name
Launcher
Version/Model Number
LA5AL105
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
K103386,K103386
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
ba29ecc5-faea-405b-a42c-759aed76d1c8
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
August 01, 2021
Package DI Number
20763000416229
Quantity per Package
5
Contains DI Package
00763000416225
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |