FDA UDI
In Commercial Distribution
🇺🇸 United States
Olympus
DI: 04042761005432
·
Model: A3661
·
OLYMPUS Winter & Ibe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 04042761005432
- Version / Model
- A3661
- Catalog Number
- A3661
- Company Name
- OLYMPUS Winter & Ibe GmbH
- Labeler DUNS
- 316957240
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-10-08
- Public Version Status
- Update
- Public Device Record Key
- d400fafc-1ab7-4b96-a97f-7654db8b8a45
Device Description
Punch, for bladder stones, optical
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 |
|---|---|---|---|---|
| GCP | Endoscope, Ac-Powered And Accessories | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32015 | Cystoscopic rongeur | A sturdy, rigid, endotherapy device used with a compatible rigid cystoscope for the removal of hard/tough tissue (e.g., calculi) in the urinary tract during a cystoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod whose distal ends are equipped with sharp-edged, scoop-shaped jaws attached to pivoted handles that, when squeezed together, close the jaws to bite (cut) through tissue. It is introduced into the body through an artificial orifice 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 | 04042761005432 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]