FDA UDI
In Commercial Distribution
🇺🇸 United States
ERAGON MODULAR
DI: 04055207056264
·
Model: 8395902
·
Richard Wolf GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ERAGON MODULAR
- Primary DI
- 04055207056264
- Version / Model
- 8395902
- Catalog Number
- 8395902
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-01
- Public Version
- 2
- Public Version Date
- 2022-12-09
- Public Version Status
- Update
- Public Device Record Key
- bf78e02e-0cc6-4955-8e58-4f4c2317427e
Device Description
SHEATH TUBE Ø 10MM SL 327MM Compatible with all ERAGONmodular 10mm inserts in the respective sheath length, along with ERAGONmodular and ERAGONaxial handles without an HF connection, reusable
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
- Yes
- 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 |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
| FCL | FORCEPS, BIOPSY, NON-ELECTRIC | Gastroenterology, Urology | 876.1075 | 1 |
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 | 04055207056264 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 10 | Millimeter | |
| Length | 327 | Millimeter |