FDA Registration
Active
🇧🇷 Brazil
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Reg #: 3013756169
·
FEI: 3013756169
·
Expires 2026
Products
21
Proprietary Names
23
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Registration Number
- 3013756169
- FEI Number
- 3013756169
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Avenida Pierre Simon de La Place, 600
- City
- Campinas Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K242311
Owner / Operator
- Firm Name
- GM dos Reis Industria e Comercio Ltda
- Operator Number
- 10059832
- Address
- Avenida Pierre Simon de La Place, 600
- City
- Campinas
- State
- Sao Paulo
- Postal Code
- 13069320
- Country
- BR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-11-04 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-05-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-05-31 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2026-02-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-03-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-03-30 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2026-02-17 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-02-27 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2022-09-06 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-08-07 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2024-06-07 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2022-08-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-05-31 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2026-02-27 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-04-17 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2022-08-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-06-15 |
| Condylar Plate Fixation Implant | JDP | Class 2 | Orthopedic | No | 2021-04-08 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2021-04-08 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-06-13 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2019-05-31 |
Proprietary Names
TEMPLATE
354-100-050 - Meniscus Suture - OUT IN
Minidriver Solaris
Screw Removal Kit
STA - ACHILLES TENDON SUTURE SYSTEM
Suture Fisher
Suture Passer
Surgical instrument
Tray, Surgical, Instrument
Meniscus Versaflex
312-500 - MULTICUTTER - Arthroscopic Retrograde Drill
359-210 - ACCESS FIT RIGHT SUTURE PASSER
335-200 - MICRO EASYPASS - SMALL CURVED MICRO SUTURE PASSER
335-100 - MICRO EASYPASS - STRAIGHT MICRO SUTURE PASSER
335-99 - MICRO EASYPASS - SHORT CURVED MICRO SUTURE PASS
335-300 - MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER
359-200 - ACCESS FIT STRAIGHT SUTURE PASSER
359-220 - ACCESS FIT LEFT SUTURE PASSER
335-600 - MICRO EASYPASS - EXTRA LARGE CURVED MICRO SUTURE PASSER
Percutaneous Foot Burrs, GMREIS
Arthodesis Burrs, GMREIS
Orthopedic manual surgical instruments
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device