FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Grasping Forceps
DI: 06970401813643
·
Model: MD-C-GF1808
·
Zhejiang Chuangxiang Medical Technology Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Single Use Grasping Forceps
- Primary DI
- 06970401813643
- Version / Model
- MD-C-GF1808
- Company Name
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- Labeler DUNS
- 544434963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 1
- Public Version Date
- 2023-02-15
- Public Version Status
- New
- Public Device Record Key
- def05c35-e308-49e6-9e2d-ba05b3b4e263
Device Description
Coating plastic on the spring tube.
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
- No
- 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 |
|---|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 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 | 06970401813643 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191900 | 000 |