FDA UDI
In Commercial Distribution
🇺🇸 United States
Olympus
DI: 04042761002134
·
Model: A0465
·
OLYMPUS Winter & Ibe GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 04042761002134
- Version / Model
- A0465
- Catalog Number
- A0465
- 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
- 4
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- fdc11111-e621-4c5e-8220-ee124f4f027e
Device Description
Adapter, telescope with Quick-Lock to TD-adapter
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 |
|---|---|---|---|---|
| EWY | Mediastinoscope, Surgical | Ear, Nose, Throat | 874.4720 | 2 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
| GCP | Endoscope, Ac-Powered And Accessories | Gastroenterology, Urology | 876.1500 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36292 | Endoscope camera adaptor | An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04042761002134 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]