FDA Registration
Active
🇺🇸 United States
BOSMA INDUSTRIES FOR THE BLIND, INC.
Reg #: 1833700
·
FEI: 1000115586
·
Expires 2026
Products
12
Proprietary Names
4
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- BOSMA INDUSTRIES FOR THE BLIND, INC.
- Registration Number
- 1833700
- FEI Number
- 1000115586
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6270 Corporate Drive
- City
- INDIANAPOLIS
- State
- IN
- ZIP
- 46278
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192954
Owner / Operator
- Firm Name
- BOSMA INDUSTRIES FOR THE BLIND, INC.
- Operator Number
- 9024211
- Address
- 6270 Corporate Drive, --
- City
- Indianapolis
- State
- IN
- Postal Code
- 46278
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-06-01 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-06-01 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-06-01 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2020-02-13 |
| Clean-Up Kit | PWU | Class 1 | General Hospital | No | 2020-03-17 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2026-03-31 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2022-11-22 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2026-03-31 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2022-11-22 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2020-03-10 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-11-22 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2021-05-07 |
Proprietary Names
Flex
Good Works Performance Pro Exam Gloves
Catheter, Urological (Straight-Tip), #10-277708-#10-277718
Vinyl patient examination glove
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device