Duns Number:948904735
Device Description: Stereotactic Drape Set - Non-Sterile
Catalog Number
-
Brand Name
Custom Medical Specialties, Inc.
Version/Model Number
CMS-5001
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
50a95612-f6fa-4ba2-bbef-0e9ec924f558
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
November 21, 2016
Package DI Number
00815849020726
Quantity per Package
10
Contains DI Package
00815849020153
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 78 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |