N/A
- Primary DI
- 04961333248902
- Brand
- N/A
- Company
- HOYA CORPORATION
- Model
- EG36-J10UR
- Device description
- PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia)
- Published
- 2021-03-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K200090 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K200090 | 000 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | Pentax of America, Inc. | 2020-07-23 | ODG |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04961333248902 | Direct Marking | GS1 | 0 | |
| 04961333248933 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04961333248902 | 04961333248902 | 4961333248902 |
| 04961333248933 | 04961333248933 | 4961333248933 |
GMDN Terms#
| Term | Definition |
|---|---|
| Flexible ultrasound gastroduodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| High-level Disinfectant;Liquid Chemical |
Regulatory Flags#
- DUNS number
- 691519705
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04961333227747 | PENTAX | BS-LC1 | 2017-04-07 | |
| 04961333228362 | PENTAX | EG-3670URK | 2017-04-07 | |
| 04961333228409 | PENTAX | EG-3870UTK | 2017-04-07 | |
| 04961333233793 | PENTAX | EG-3270UK | 2018-08-10 | |
| 04961333254316 | PENTAX | EC-2990Li | 2024-07-26 | |
| 04961333254323 | PENTAX | EC34-i10L | 2024-07-26 | |
| 04961333254330 | PENTAX | EC-3890TLK | 2024-07-26 | |
| 04961333254347 | PENTAX | EC38-i10L | 2024-07-26 | |
| 04961333254354 | PENTAX | EC-3890Li | 2024-07-26 | |
| 04961333254385 | PENTAX | EG-2490K | 2024-07-26 | |
| 04961333254392 | PENTAX | EG27-i10 | 2024-07-26 | |
| 04961333254408 | PENTAX | EG-2990i | 2024-07-26 | |
| 04961333254422 | PENTAX | EG29-i10 | 2024-07-26 | |
| 04961333254439 | PENTAX | EG-3890TK | 2024-07-26 | |
| 04961333255238 | VIVIDEO | CP-1000 | 2025-12-19 | |
| 04961333255306 | VIVIDEO | VNL9-CP | 2025-12-19 | |
| 04961333255191 | VIVIDEO | CP-1000 | 2025-12-19 | |
| 04961333255245 | VIVIDEO | VNL9-CP | 2025-12-19 | |
| 04961333254620 | PENTAX Medical | OE-B17 | 2024-12-13 | |
| 04961333077731 | PENTAX | OF-B161 | 2023-07-31 |
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