FDA UDI
In Commercial Distribution
🇺🇸 United States
HiFocus™ Electrode Forceps Kit
DI: 07630016852886
·
Model: CI-4350-02
·
Advanced Bionics AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HiFocus™ Electrode Forceps Kit
- Primary DI
- 07630016852886
- Version / Model
- CI-4350-02
- Company Name
- Advanced Bionics AG
- Labeler DUNS
- 485262658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-15
- Public Version
- 8
- Public Version Date
- 2024-02-22
- Public Version Status
- Update
- Public Device Record Key
- e955e79a-e61d-4f6b-a0c4-25966ec93b08
- Distribution End Date
- 2024-05-26
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MCM | Implant, Cochlear | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42500 | Dressing/utility forceps, tweezers-like, reusable | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07630016819438 | GS1 | ||||
| Primary | 07630016852886 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 121 |