FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 16926839812458
·
Model: M00591230
·
Anrei Medical(HZ) Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 16926839812458
- Version / Model
- M00591230
- Catalog Number
- M00591230
- Company Name
- Anrei Medical(HZ) Co.,Ltd.
- Labeler DUNS
- 529128653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-27
- Public Version
- 2
- Public Version Date
- 2025-12-11
- Public Version Status
- Update
- Public Device Record Key
- 3c1343bc-5c4f-46e8-9a7e-81cb22a134e3
Device Description
Single-Use Snare
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GAE | Snare, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62615 | Mechanical-cutting endoscopic polypectomy snare | A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26926839812462 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 16926839812458 | GS1 | ||||
| Package | 26926839812479 | GS1 | 20 | In Commercial Distribution |