FDA UDI
In Commercial Distribution
🇺🇸 United States
Omni® Hysteroscopic Grasper
DI: 06974880994343
·
Model: OMNI-G-DSI-001
·
Suzhou AcuVu medical technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Omni® Hysteroscopic Grasper
- Primary DI
- 06974880994343
- Version / Model
- OMNI-G-DSI-001
- Company Name
- Suzhou AcuVu medical technology Co., Ltd.
- Labeler DUNS
- 705464292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- a0967adc-e64b-41ae-b719-74d8ae5a9d28
Device Description
The sterile, single-use, hand actuated Hysteroscopic Grasper is used for traction of soft intrauterine tissue and is compatible with the MyoSure® Hysteroscopic Tissue Removal System and Omni® Hysteroscope.
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 |
|---|---|---|---|---|
| NWW | Hysteroscope Accessories | Obstetrics/Gynecology | 884.1690 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35080 | Rigid endoscopic tissue manipulation forceps, reusable | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26974880994347 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 06974880994343 | GS1 |