FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EasyShaft 5 S
DI: EAMIESH15100
·
Model: ESH1510
·
AMI Agency for Medical Innovations GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EasyShaft 5 S
- Primary DI
- EAMIESH15100
- Version / Model
- ESH1510
- Catalog Number
- ESH1510
- Company Name
- AMI Agency for Medical Innovations GmbH
- Labeler DUNS
- 303655286
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-05
- Public Version
- 3
- Public Version Date
- 2023-11-28
- Public Version Status
- Update
- Public Device Record Key
- 4c7d4ea0-e6ec-4d94-8249-d17abf4a9677
- Distribution End Date
- 2023-11-21
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 44680 | Electrosurgical handpiece, reusable | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAMIESH15100 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 250 | Millimeter | |
| Outer Diameter | 5 | Millimeter |