FDA Registration
Active
🇲🇽 Mexico
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
Reg #: 9680794
·
FEI: 3003737899
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Arrow Internacional de Chihuahua S.A. de C.V.
- Registration Number
- 9680794
- FEI Number
- 3003737899
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ave. Washington 3701, Interior Circuito Industrial, Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana
- City
- CHIHUAHUA
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K946173
Owner / Operator
- Firm Name
- Arrow International LLC (subsidiary of Teleflex Incorporated
- Operator Number
- 2518433
- Address
- 3015 Carrington Mill Blvd.
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Divya Raman
US Agent
- Business Name
- Teleflex, Inc.
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2016-02-29 |
Proprietary Names
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device