Duns Number:063519193
Device Description: Gems C-arm Equipment Covers Blue Polyethylene Sterile Fits Innova 3100 12 per Case
Catalog Number
-
Brand Name
Gems
Version/Model Number
30728
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
e71d34ce-f180-4a63-80cc-61cbb8de33de
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 24, 2022
Package DI Number
10618125158277
Quantity per Package
12
Contains DI Package
00618125158270
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 |