Duns Number:084527241
Catalog Number
6977-7512
Brand Name
HOSE SET, ADVANCE CONTROL PADS
Version/Model Number
6977-750
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
b0e719d5-2939-4b37-954e-64b88130d5ad
Public Version Date
September 24, 2021
Public Version Number
3
DI Record Publish Date
August 05, 2019
Package DI Number
10842430105880
Quantity per Package
12
Contains DI Package
00842430105883
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 | 1076 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |