FDA Registration
Active
🇲🇽 Mexico
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 5-1/4", Medium
Reg #: 3007392395
·
FEI: 3007392395
·
Expires 2025
Products
1
Proprietary Names
57
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Zeffer Research & Assoc. S. A. de C. V.
- Registration Number
- 3007392395
- FEI Number
- 3007392395
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Calle Cuarzo S/N Manzana 25 Lote 7 y 8, Maneadero
- City
- Ensenada Baja California
- Country
- MX
Owner / Operator
- Firm Name
- TIBURON MEDICAL ENTERPRISES
- Operator Number
- 9040187
- Address
- 915 INDUSTRIAL WAY, --
- City
- San Jacinto
- State
- CA
- Postal Code
- 92582
- Country
- US
- Correspondent
- JUAN C ORDAZ
US Agent
- Business Name
- TIBURON MEDICAL ENTERPRISES, INC
- Contact Name
- JUAN ORDAZ
- Address
- 915 INDUSTRIAL WAY
- City
- San Jacinto
- State
- CA
- ZIP
- 92582
- Country
- US
- [email protected]
- Phone
- 951 6542333
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2004-02-05 |
Proprietary Names
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 5-1/4", Medium
Replacement Back Pad, for PNC, Standard
RP Clavicle Strap, Xtr Small
ADJ KYDEX CERVICAL COLLAR,SNAP
Back Panel with Pad for PNC Neck Brace, Tall
Trach Cervical Collar, 3-1/4", Large
Plastic Stays for WFC, Univ.
Trach Cervical Collar, 5-1/4", Medium
Cover for Foam Collar, Medium
RP Clavicle Strap, Small
ADJ KYDEX CERVICAL, VELCRO
Trach Cervical Collar, Ped
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 5-1/4", Large
Trach Cervical Collar, 3-1/4", Small
Repl. Cover & Strap, WFC, Med
Back Panel with Pad for PNC Neck Brace, Short
PNC Neck Brace, Complete, 3-3/4", Tall
Trach Cervical Collar, 4-1/4", Large
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 4-1/4", Medium
PNC Neck Brace Complete 3", Average
Trach Cervical Collar, 4-1/4", Medium
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 4-1/4", Large
Trach Cervical Collar, 2-1/4", Medium
RP Clavicle Strap, Large
Occipital Support for WFC, Uni
Wire Frame Collar, Small
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 3-1/4" Medium
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 2-1/4" Large
Trach Cervical Collar, 3-1/4", Medium
Repl. Cover & Strap, WFC, Lg
Repl. Liner for Occ. Sup., Uni
Back Panel with Pad for PNC Neck Brace, Standard
PNC Neck Brace, Complete 4-1/2", Extra Tall
Trach Cervical Collar, 5-1/4", Small
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 2-1/4" Small
Replacement Back Pad, for PNC, Small
RP Clavicle Strap, Medium
Trach Cervical Collar, 2-1/4", Small
Trach Cervical Coll Ortiz, Ped
Cover for Foam Collar, Large
Replacement Front and Back Pad set for PNC Brace, Standard
LINER, REPLACEMENT, FOAM & WIRE CERVICAL COLLAR, ADULT
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 2-1/4" Medium
Wire Frame Collar, Large
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 4-1/4", Small
Trach Cervical Collar, 5-1/4", Large
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 5-1/4", Small
Trach Cervical Collar, 2-1/4" Large
Repl. Cover & Strap, WFC, Sm
T.C.C. Halo
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 3-1/4" Small
Wire Frame Collar, Medium
Trach Cervical Collar, Ortiz Stamped on strap, No Insert, 3-1/4" Large
Cover for Foam Collar, Small
PNC Neck Brace, Complete, 2-1/4", Short
Trach Cervical Collar, 4-1/4", Small
Replacement Back Pad (Foam Only), for PNC, Large
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device