FDA UDI
In Commercial Distribution
🇺🇸 United States
PENTAX Medical
DI: 04961333356355
·
Model: ED34-i10T2s
·
HOYA CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PENTAX Medical
- Primary DI
- 04961333356355
- Version / Model
- ED34-i10T2s
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-03
- Public Version
- 1
- Public Version Date
- 2024-09-11
- Public Version Status
- New
- Public Device Record Key
- dfbc3556-a75f-4cb1-a6da-a474fdb1d674
Device Description
PENTAX Medical Video Duodenoscope ED34-i10T2s
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, Liquid Chemical, Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDT | duodenoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36112 | Flexible video duodenoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04961333356331 | GS1 | ||||
| Primary | 04961333356355 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233942 | 000 |