Duns Number:256880576
Device Description: MEDICOM SAFEWEAR HIP JACKET BLACK Medium
Catalog Number
8118-B
Brand Name
MEDICOM SAFEWEAR
Version/Model Number
8118-B
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
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
91a7645f-b1aa-4a44-8410-4c33a5128488
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 17, 2019
Package DI Number
20686864055703
Quantity per Package
5
Contains DI Package
10686864055706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |