FDA UDI
In Commercial Distribution
🇺🇸 United States
Dornier MedTech
DI: 00810116021697
·
Model: Bipolar Needle 24 Fr. Electrode-Sterile, Single-Use. (6/box)
·
DORNIER MEDTECH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dornier MedTech
- Primary DI
- 00810116021697
- Version / Model
- Bipolar Needle 24 Fr. Electrode-Sterile, Single-Use. (6/box)
- Catalog Number
- BIPNEEL
- Company Name
- DORNIER MEDTECH AMERICA, INC.
- Labeler DUNS
- 130789944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 1
- Public Version Date
- 2020-06-29
- Public Version Status
- New
- Public Device Record Key
- 34b5b59b-90ae-4bb0-875b-c26fd101261d
Device Description
Bipolar Needle 24 Fr. Electrode-Sterile, Single-Use. (6/box)
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61872 | Endoscopic electrosurgical electrode, bipolar, single-use | An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810116021765 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00810116021697 | GS1 |