FDA UDI
In Commercial Distribution
🇺🇸 United States
DUFNER Instrumente GmbH
DI: 04063763178986
·
Model: 27996-01
·
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
- 04063763178986
- Version / Model
- 27996-01
- 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
- 93e9181f-f92c-4de7-89ae-c383c78d3aad
Device Description
MICTEC Biopsy forceps, pistol grip, with cleaning flush port, Ø 2.0 mm, 240 mm working length
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 |
|---|---|---|---|---|
| 35732 | Rigid endoscopic biopsy forceps, reusable | A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04063763178986 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |