FDA Registration
Active
🇺🇸 United States
CUSTOM ASSEMBLIES, INC.
Reg #: 1063382
·
FEI: 3000718854
·
Expires 2026
Products
12
Proprietary Names
12
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- CUSTOM ASSEMBLIES, INC.
- Registration Number
- 1063382
- FEI Number
- 3000718854
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 330 EAST MAIN STREET
- City
- PINE LEVEL
- State
- NC
- ZIP
- 27568
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993463
Owner / Operator
- Firm Name
- CUSTOM ASSEMBLIES, INC.
- Operator Number
- 9026626
- Address
- 330 E. Main St., --
- City
- Pine Level
- State
- NC
- Postal Code
- 27568
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2023-07-20 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2013-07-08 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2021-05-11 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2016-12-07 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2021-07-28 |
| Restraint, Wheelchair, Non-Protective | KID | Class 1 | Physical Medicine | No | 2016-11-18 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-02-03 |
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 2016-11-18 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2012-12-14 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2012-01-20 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2016-11-18 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2023-07-26 |
Proprietary Names
Drain Bag
General Surgery Tray
Needle Holder
Pressure Tubing
Injection Cannula
Restraint
Drape, Surgical Exempt
Balloon Catheter
Tubing, Noninvasive- CMS
IV Set
TABLE AND ATTACHMENTS, OPERATING-ROOM
Microtome Accessories
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)