LSI Silver Self Adhesive, Disposable Electrodes 300-138
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850689007964 | Date1 Sep 2016 | StatusListed |
Recalls
-
- Terminated Z-0815-2013
- Terminated Z-0816-2013
- Terminated Z-0818-2013
- Terminated Z-0817-2013
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- LSI Silver Self Adhesive, Disposable Electrodes
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use
- Model / Reference
- 300-138
- Primary DI / UDI-DI
- 00850689007964
- 510(k) Number
- FDA Product Code
- GXY
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use
- Device Class
- Class II
- Regulation Number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
Other devices from Drive Devilbiss Healthcare
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No