FDA UDI
In Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147001879
·
Model: 20150-220
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ERBE
- Primary DI
- 04050147001879
- Version / Model
- 20150-220
- Catalog Number
- 20150-220
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 4
- Public Version Date
- 2024-02-14
- Public Version Status
- Update
- Public Device Record Key
- 06bd3083-1c37-40df-a583-593939337d91
Device Description
ERBEJET® probe, flexible ø 1,3 mm; L 2,2 m
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 |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47559 | Water jet knife system handpiece, single-use | A sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04050147015418 | GS1 | Level: 1 | 5 | In Commercial Distribution | |
| Primary | 04050147001879 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2.200 | Meter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry