FDA UDI
In Commercial Distribution
🇺🇸 United States
DUFNER Instrumente GmbH
DI: 04063763200625
·
Model: 20943-14
·
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DUFNER Instrumente GmbH
- Primary DI
- 04063763200625
- Version / Model
- 20943-14
- Company Name
- DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- Labeler DUNS
- 327980801
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 1
- Public Version Date
- 2024-03-19
- Public Version Status
- New
- Public Device Record Key
- 40dd62aa-2998-4566-bd91-c3d87d1ee801
Device Description
MICTEC Suction tube with basket, big central opening, 30° curved, Ø 4.5 mm, 300 mm working length Luer lock connector
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31793 | Boiling water sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical/dental devices and related products using boiling water as the sterilizing agent. It typically consists of a container intended to be filled with water, in which devices are submerged, and an apparatus to boil the water for a specific period. The device is almost exclusively used in remote areas, at home (e.g., for baby bottle sterilization), and/or in emergency situations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04063763200625 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |