FDA Registration
Active
🇺🇸 United States
GD Group USA Company
Reg #: 3009542933
·
FEI: 3009542933
·
Expires 2026
Products
20
Proprietary Names
20
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- GD Group USA Company
- Registration Number
- 3009542933
- FEI Number
- 3009542933
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1286 Humbracht Cir
- City
- Bartlett
- State
- IL
- ZIP
- 60103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001858
Owner / Operator
- Firm Name
- GD Group USA Company
- Operator Number
- 10040438
- Address
- 1286 Humbracht Circle Suite A
- City
- Bartlett
- State
- IL
- Postal Code
- 60103
- Country
- US
- Correspondent
- Guangyu Zhang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-04-13 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2012-04-13 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-14 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2012-04-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2012-04-13 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2012-04-13 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-04-13 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2012-04-13 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2012-04-13 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2012-04-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-04-13 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2012-04-13 |
Proprietary Names
FIBER, MEDICAL, ABSORBENT
CAP, SURGICAL
Counter, sponge, surgical
Drape, Surgical, Exempt
DRAPE, SURGICAL
BANDAGE, ELASTIC
COVER, SHOE, OPERATING-ROOM
COTTON, ROLL
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Non-surgical isolation gown
DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
Tape and bandage, adhesive
PAD, EYE
DISSECTOR, TONSIL
BEDDING, DISPOSABLE, MEDICAL
SHEET, BURN
GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
ACCESSORY, SURGICAL APPAREL
DRESSING,WOUND,HYDROPHILIC
GOWN, EXAMINATION
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility