FDA UDI
In Commercial Distribution
🇺🇸 United States
PENTAX
DI: 04961333223985
·
Model: FG-24V
·
HOYA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PENTAX
- Primary DI
- 04961333223985
- Version / Model
- FG-24V
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-07
- Public Version
- 4
- Public Version Date
- 2018-09-27
- Public Version Status
- Update
- Public Device Record Key
- a3818e0a-d821-448d-a2ae-e32e03d941b8
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
- ["High-level Disinfectant", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDS | Gastroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35088 | Flexible fibreoptic gastroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333223985 | GS1 | ||||
| Direct Marking | 04961333166503 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K850020 | 000 |