Duns Number:068156330
Device Description: TE: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M MULT TE: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M MULTILEAD LEADWIRE (5-LEAD), COLOR GROUP T5
Catalog Number
-
Brand Name
Rochester
Version/Model Number
S85015-T5-10SC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2019
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
-
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
00f002d5-be0d-46a7-b62a-401779aba5b4
Public Version Date
May 21, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10816843023093
Quantity per Package
10
Contains DI Package
10816843023109
Package Discontinue Date
May 20, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 83 |