Duns Number:167450993
Device Description: Coleman Luer Lock Cap
Catalog Number
COL-LLCAP
Brand Name
Coleman Luer Lock Cap
Version/Model Number
COL-LLCAP
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
K981172,K981172,K981172
Product Code
MUU
Product Code Name
System, suction, lipoplasty
Public Device Record Key
99ce393b-b73f-4ad7-afab-f005d962117c
Public Version Date
November 09, 2021
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
10081317023484
Quantity per Package
25
Contains DI Package
00081317023487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
25 Pouches/Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 128 |
3 | A medical device with high risk that requires premarket approval | 545 |
U | Unclassified | 514 |