FDA UDI
In Commercial Distribution
🇺🇸 United States
Sutter
DI: ESUM780169SLS0
·
Model: 780169SLS
·
Sutter Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sutter
- Primary DI
- ESUM780169SLS0
- Version / Model
- 780169SLS
- Catalog Number
- 780169SLS
- Company Name
- Sutter Medizintechnik GmbH
- Labeler DUNS
- 316625425
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-09
- Public Version
- 3
- Public Version Date
- 2022-07-25
- Public Version Status
- Update
- Public Device Record Key
- 0f17abf7-ecea-434b-bca0-32bad0ff9bb5
Device Description
Bipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 0.4 x 6.0mm
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 47848 | Open-surgery electrosurgical handpiece/electrode, bipolar, reusable | A rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ESUM780169SLS0 | HIBCC |
Customer Contacts
- Phone
- +49761515510
- [email protected]