FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04055207010730
·
Model: 859202
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04055207010730
- Version / Model
- 859202
- Catalog Number
- 8592.02
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-05-23
- Public Version Status
- Update
- Public Device Record Key
- d0ea64d2-58e3-43ed-ab31-e20db2f6886d
- Distribution End Date
- 2018-11-30
Device Description
ORIFICE DILATOR 15FR WL 119MM metal, TL 114mm, 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOE | DILATOR, URETHRAL | Gastroenterology, Urology | 876.5520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14286 | Urethral bougie, reusable | A rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207010730 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 119 | Millimeter | |
| Lumen/Inner Diameter | 5 | Millimeter |