Duns Number:014464314
Device Description: Coulmed C-Arm Kit XXIII (equipment covers only)
Catalog Number
DI-5404
Brand Name
Coulmed
Version/Model Number
DI-5404
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
K101689,K101689
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
2ed740d6-a040-4764-8536-dea86b5d3682
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2019
Package DI Number
00850003355313
Quantity per Package
20
Contains DI Package
00850003355306
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 489 |