FDA UDI
In Commercial Distribution
🇺🇸 United States
PENTAX Medical
DI: 04961333247462
·
Model: OS-A115
·
HOYA CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PENTAX Medical
- Primary DI
- 04961333247462
- Version / Model
- OS-A115
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 2
- Public Version Date
- 2024-02-15
- Public Version Status
- Update
- Public Device Record Key
- af0f83bd-de2b-4e3b-bbf5-f20efd886e74
Device Description
PENTAX Medical Keyboard EN OS-A115
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | Gastroenterology, Urology | 876.1500 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62940 | Computer/medical device keyboard | A desktop, electronic component of a computer/medical device intended to operate and/or control the use of the parent device. It has a panel of keys, including alpha-numeric characters, and may have touchscreen capability and/or specialized keys to control specialized functionality of the parent device. It is not dedicated to those with a disability. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333247462 | GS1 |