FDA UDI
In Commercial Distribution
🇺🇸 United States
PENTAX Medical
DI: 04961333254620
·
Model: OE-B17
·
HOYA CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PENTAX Medical
- Primary DI
- 04961333254620
- Version / Model
- OE-B17
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 2
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- faf58b8b-3acf-484e-a679-c3d5e4efa776
Device Description
PENTAX Medical R/L Assistant Knob OE-B17
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
- Yes
- Sterilization Methods
- High-level Disinfectant, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64376 | Device control handling knob, reusable | A hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333254620 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241213 | 000 |