FDA UDI
In Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147001930
·
Model: 20150-300
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ERBE
- Primary DI
- 04050147001930
- Version / Model
- 20150-300
- Catalog Number
- 20150-300
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b17e9027-005c-4412-9e01-ebad378a8c41
Device Description
Pump cartridge for ERBEJET® 2
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 |
|---|---|---|---|---|
| 62356 | Water jet knife system pump-cartridge | A sterile, non-electrical component of a water jet knife system intended to be inserted into the system’s generator to pressurize a fluid medium, typically sterile saline, and conduct the resulting high-pressure stream to the system’s handpiece for soft-tissue cutting and submucosal injection during surgery. It is in the form of a plastic housing containing pistons mechanically powered by the generator; it includes a port for connection to the handpiece, which may facilitate changing of the handpiece intraoperatively. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04050147015470 | GS1 | Level: 1 | 5 | In Commercial Distribution | |
| Primary | 04050147001930 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072404 | 000 |
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