FDA Registration
Active
🇲🇽 Mexico
Stryker 8001-063-409 Series Esophageal/Rectal Temp Probe, 21651-4491
Reg #: 3030089838
·
FEI: 3030089838
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- TE Sensores S. de R.L. de C.V
- Registration Number
- 3030089838
- FEI Number
- 3030089838
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av. Obrero Mundial No. 9, Parque Industrial Dynatech, Colonia el Sahuaro
- City
- Hermosillo Mexico
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K883793
Owner / Operator
- Firm Name
- TE Connectivity
- Operator Number
- 10089420
- Address
- 1740 Joe Battle Blvd, Bldg. 3
- City
- El Paso
- State
- TX
- Postal Code
- 79936
- Country
- US
- Correspondent
- Delton Carter
US Agent
- Business Name
- TE CONNECTIVITY
- Contact Name
- Delton Carter
- Address
- 1740 Joe Battle Blvd, Bldg 3
- City
- El Paso
- State
- TX
- ZIP
- 79936
- Country
- US
- [email protected]
- Phone
- 980 2696234
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-11-21 |
Proprietary Names
Stryker 8001-063-409 Series Esophageal/Rectal Temp Probe, 21651-4491
Stryker 8001-063-412 Series Esophageal/Rectal Temp Probe, 21651-4492
MEAS 4400 Series 9FR ESOPH/REC Temp Probe, 4491
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device