FDA UDI
In Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147020092
·
Model: 20150-215
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ERBE
- Primary DI
- 04050147020092
- Version / Model
- 20150-215
- Catalog Number
- 20150-215
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 9845844e-8a17-4179-8c72-eba6898c2c00
Device Description
HybridAPC probe OD 2.3mm; L 1.9m
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
- 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
- No
- 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 |
|---|---|---|---|---|
| 62227 | Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument | A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by gas plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to a parent device (i.e., inert gas-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include controls. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04050147020108 | GS1 | Level: 1 | 5 | In Commercial Distribution | |
| Primary | 04050147020092 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143306 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.900 | Meter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and direct sunlight