FDA UDI
In Commercial Distribution
🇺🇸 United States
Single-Use Choledochoscope
DI: 06970462546351
·
Model: CH-M52H
·
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Single-Use Choledochoscope
- Primary DI
- 06970462546351
- Version / Model
- CH-M52H
- Company Name
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Labeler DUNS
- 403655303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-11
- Public Version
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- 7b2e4083-f45d-44cb-a584-882d6fa67cc8
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64055 | Flexible video choledochoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. Also known as a cholangioscope, it is inserted into the body through an artificial orifice or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to a monitor for viewing typically through a complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970462546358 | GS1 | CASE | 10 | Not in Commercial Distribution | 2024-06-11 |
| Primary | 06970462546351 | GS1 | ||||
| Package | 26970462546355 | GS1 | CASE | 5 | Not in Commercial Distribution | 2024-06-11 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231497 | 000 |