FDA UDI
In Commercial Distribution
🇺🇸 United States
Single use biopsy forceps PGB
DI: 06971176281521
·
Model: PGB
·
Zhuhai Pusen Medical Technology Co, Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single use biopsy forceps PGB
- Primary DI
- 06971176281521
- Version / Model
- PGB
- Company Name
- Zhuhai Pusen Medical Technology Co, Ltd
- Labeler DUNS
- 544427443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-11
- Public Version
- 1
- Public Version Date
- 2025-02-19
- Public Version Status
- New
- Public Device Record Key
- 3e9b458c-02b4-43dd-9ea9-fcea21ca3fd1
Device Description
The single use biopsy forceps is intended to be used through working channel of endoscope to remove tissue samples.
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
- 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 | 16971176281528 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 06971176281521 | GS1 | ||||
| Package | 26971176281525 | GS1 | carton | 20 | In Commercial Distribution |