Duns Number:117606791
Device Description: The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures.
Catalog Number
-
Brand Name
Isolaer Aerosol Isolation Barrier
Version/Model Number
IB-1000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ERY
Product Code Name
Drape, Surgical, Ent
Public Device Record Key
f05fb89b-b8a5-4a3a-9d91-e3dff05620d8
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |