FDA UDI
In Commercial Distribution
🇺🇸 United States
Anrei
DI: 06926839810846
·
Model: 699 001 000
·
Anrei Medical(HZ) Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Anrei
- Primary DI
- 06926839810846
- Version / Model
- 699 001 000
- 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
- 2025-07-03
- Public Version
- 1
- Public Version Date
- 2025-07-11
- Public Version Status
- New
- Public Device Record Key
- cb4096bf-cf26-45a0-9f53-96b1e43aedbf
Device Description
Ambu® Cysto Grasper
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
- 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 |
|---|---|---|---|---|
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33199 | Flexible endoscopic tissue manipulation forceps, single-use | A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16926839810843 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 06926839810846 | GS1 | ||||
| Package | 26926839810840 | GS1 | Box | 10 | In Commercial Distribution |