Duns Number:427895198
Device Description: Surgical Drape for use with the SurgiCube air flow units are intended to be used as a ster Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles.
Catalog Number
-
Brand Name
SurgiCube drape
Version/Model Number
SCDR180
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
HMT
Product Code Name
Drape, Patient, Ophthalmic
Public Device Record Key
2270f729-40f8-479a-9ece-871c74a0181a
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
December 10, 2020
Package DI Number
07350101640081
Quantity per Package
42
Contains DI Package
07350101640098
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cartong box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |