Duns Number:602465783
Device Description: SafeOp EMG/NMJ Needle Electrode & SSEP Needle Electrode Procedure Kit
Catalog Number
-
Brand Name
SafeOp
Version/Model Number
AIX1203A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182542
Product Code
GXZ
Product Code Name
ELECTRODE, NEEDLE
Public Device Record Key
3cbe1686-5c06-4a44-84e1-df23de7a9ce9
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 31, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5644 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26570 |
| U | Unclassified | 15 |