FDA UDI
In Commercial Distribution
🇺🇸 United States
CycloTens Refill Pak
DI: 00370914013015
·
Model: 50054A
·
HUDSON SCIENTIFIC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CycloTens Refill Pak
- Primary DI
- 00370914013015
- Version / Model
- 50054A
- Company Name
- HUDSON SCIENTIFIC, LLC
- Labeler DUNS
- 080339637
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 40fa0a53-b6b9-4b55-ad90-6af881af4c39
Device Description
One bottle 30 ct. Cyclobenzaprine 10 mg with one set of Tens Unit Electrode pads
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35751 | Transcutaneous electrical stimulation lead | A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20370914013019 | GS1 | 120 | In Commercial Distribution | ||
| Primary | 00370914013015 | GS1 | ||||
| Package | 10370914013012 | GS1 | Shipper Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 5172124047
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133979 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 80 Degrees Fahrenheit