FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06950190439217
·
Model: ES-DISP-SCS
·
Zhuji Pengtian Medical Instrument Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 06950190439217
- Version / Model
- ES-DISP-SCS
- Catalog Number
- PTA-17046SB
- Company Name
- Zhuji Pengtian Medical Instrument Co.,Ltd.
- Labeler DUNS
- 421253617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-14
- Public Version
- 1
- Public Version Date
- 2021-04-22
- Public Version Status
- New
- Public Device Record Key
- e50f0e66-4cbd-4e12-ba00-e42c43c4aea1
Device Description
Disposable Single-Action Scissors
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| LRW | Scissors, General, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46420 | Flexible endoscopic scissors, single-use | A flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16950190439214 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 06950190439217 | GS1 |