FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PENTAX
DI: 04961333224166
·
Model: FB-15V
·
HOYA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PENTAX
- Primary DI
- 04961333224166
- Version / Model
- FB-15V
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-07
- Public Version
- 5
- Public Version Date
- 2022-12-16
- Public Version Status
- Update
- Public Device Record Key
- 7608203d-3fca-4b87-90a9-07841b985bef
- Distribution End Date
- 2019-05-29
Device Description
Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35461 | Flexible fibreoptic bronchoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333224166 | GS1 | ||||
| Direct Marking | 04961333072798 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951199 | 000 |