FDA UDI
In Commercial Distribution
🇺🇸 United States
Endoch
DI: EAI0787
·
Model: EAI-0787
·
Endoch Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Endoch
- Primary DI
- EAI0787
- Version / Model
- EAI-0787
- Catalog Number
- EAI-0787
- Company Name
- Endoch Inc
- Labeler DUNS
- 241382683
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-01
- Public Version
- 1
- Public Version Date
- 2019-06-10
- Public Version Status
- New
- Public Device Record Key
- 305beb61-7f92-4f76-9e8d-a2af72c81423
Device Description
DISPOSABLE LAPAROSCOPIC METZENBAUM SCISSORS, CURVED
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
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
| JOK | Scissors, Medical, Disposable | General Hospital | 880.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63163 | Rigid endoscopic scissors, single-use | A sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAI0787 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171825 | 000 |