Duns Number:041674552
Device Description: Patient Restraint Waist Strap, Burgundy
Catalog Number
Not Applicable
Brand Name
MedSource Straps
Version/Model Number
MS-ST610
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
-
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
d60bd7cc-36f1-4547-a136-c0e0f7f23f97
Public Version Date
January 12, 2022
Public Version Number
1
DI Record Publish Date
January 04, 2022
Package DI Number
00840155412248
Quantity per Package
20
Contains DI Package
00840155412224
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |