FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06959664913499
·
Model: AG-5591-01
·
Hangzhou AGS MedTech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 06959664913499
- Version / Model
- AG-5591-01
- Company Name
- Hangzhou AGS MedTech Co., Ltd.
- Labeler DUNS
- 542984702
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-31
- Public Version
- 2
- Public Version Date
- 2023-05-29
- Public Version Status
- Update
- Public Device Record Key
- a02edddb-8855-4b46-ae77-67e32289f57f
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61378 | Endoscopic guidewire holder | A device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16959664913496 | GS1 | box | 25 | In Commercial Distribution | |
| Primary | 06959664913499 | GS1 | ||||
| Package | 26959664913493 | GS1 | carton | 50 | In Commercial Distribution |