Duns Number:008124539
Device Description: Shroud Kit that contains (1) CPE Shroud Wrap, (1) PP Chin Binder, (1) Underpad, (3) Toe Ta Shroud Kit that contains (1) CPE Shroud Wrap, (1) PP Chin Binder, (1) Underpad, (3) Toe Tag with 36", (2) Thread 60", Introduction Sheet, Heat-Sealed Polybag
Catalog Number
-
Brand Name
Shroud Kit
Version/Model Number
4771
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
f2e31c25-671e-401a-a385-fb6c80dad861
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784477138
Quantity per Package
50
Contains DI Package
00616784477121
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |