FDA UDI
In Commercial Distribution
🇺🇸 United States
LaproShear
DI: 10860006484825
·
Model: 120-7000
·
Surgical Principals, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- LaproShear
- Primary DI
- 10860006484825
- Version / Model
- 120-7000
- Company Name
- Surgical Principals, Inc
- Labeler DUNS
- 782873892
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-11-19
- Public Version
- 2
- Public Version Date
- 2025-03-03
- Public Version Status
- Update
- Public Device Record Key
- e1dc7ccd-b2de-40b8-a831-fafa6a7853f4
Device Description
Laparoscopic Scissor 5mm 3/4 inch Metz Scissor Shaft, 33cm
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use | An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00860006484828 | GS1 | ||||
| Primary | 10860006484825 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210569 | 000 |