Duns Number:063519193
Device Description: Drapetech C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC Miniview 6800 20 per Drapetech C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC Miniview 6800 20 per Case
Catalog Number
-
Brand Name
Drapetech
Version/Model Number
28383
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
420cbf3c-5960-4b3e-8593-a7a5ad51f0c9
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
Package DI Number
10618125157423
Quantity per Package
20
Contains DI Package
00618125157426
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |