Duns Number:025460908
Device Description: YANK,FLEX HNDL,REG CAPACITY,1/4X6' TUB
Catalog Number
OR6166
Brand Name
Medline
Version/Model Number
OR6166
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAZ
Product Code Name
TUBING, NONINVASIVE
Public Device Record Key
b83f902d-b862-453b-944c-1d3fbd044a4a
Public Version Date
January 11, 2021
Public Version Number
1
DI Record Publish Date
January 02, 2021
Package DI Number
20888277656717
Quantity per Package
20
Contains DI Package
10888277656710
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 | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |