FDA UDI
In Commercial Distribution
🇺🇸 United States
VersaGrasp Single use Grasping Forceps
DI: 06948318996094
·
Model: M0067802000
·
Anrei Medical(HZ) Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VersaGrasp Single use Grasping Forceps
- Primary DI
- 06948318996094
- Version / Model
- M0067802000
- Catalog Number
- M0067802000/M0067802001
- 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
- 2023-11-01
- Public Version
- 2
- Public Version Date
- 2023-11-14
- Public Version Status
- Update
- Public Device Record Key
- 48385ad6-c6c1-47dd-8c1d-58153cc6adb2
Device Description
This instrument has been designed to be used with an endoscope to retrieve foreign bodies or resected tissue from the urinary system transurethrally.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|---|---|
| Primary | 06948318996094 | GS1 | ||||
| Package | 16948318996091 | GS1 | cassette | 5 | In Commercial Distribution |