FDA UDI
In Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147022966
·
Model: 20150-112
·
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
- 04050147022966
- Version / Model
- 20150-112
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 1
- Public Version Date
- 2024-03-07
- Public Version Status
- New
- Public Device Record Key
- a622764b-8716-4dee-adba-65d1721b6d46
Device Description
HYBRIDknife® flex I-Type E-short; OD 2.6mm; L 2.3m
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 |
|---|---|---|---|---|
| 62228 | Endoscopic electrosurgical submucosal lift/resection instrument | A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It is a long, thin electrode/luminal needle with an electrical cable and delivery tube to enable connection to the appropriate parent devices (i.e., electrosurgical system generator and fluid pump); it does not include any 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 | 04050147023000 | GS1 | Level: 1 | 5 | In Commercial Distribution | |
| Primary | 04050147022966 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232033 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2.3 | Meter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry