FDA UDI
In Commercial Distribution
🇺🇸 United States
PENTAX Medical
DI: 04961333253890
·
Model: PVK-J10
·
HOYA CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PENTAX Medical
- Primary DI
- 04961333253890
- Version / Model
- PVK-J10
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-13
- Public Version
- 1
- Public Version Date
- 2023-03-21
- Public Version Status
- New
- Public Device Record Key
- 8f0a5221-5f85-42b7-9397-7679ab626cf1
Device Description
PENTAX Medical Camera Head PVK-J10
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
- ["High-level Disinfectant", "Hydrogen Peroxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
| EQL | Laryngostroboscope | Ear, Nose, Throat | 874.4750 | 1 |
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35958 | Endoscope video camera | An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04961333246274 | GS1 | ||||
| Primary | 04961333253890 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220465 | 000 |