FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EYEPIECE CAP
DI: 04953170063749
·
Model: MB-147
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EYEPIECE CAP
- Primary DI
- 04953170063749
- Version / Model
- MB-147
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-20
- Public Version
- 3
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- e146c352-7206-4ab2-a9f4-ebe403544ece
- Distribution End Date
- 2022-08-12
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65470 | Scope eyepiece attachment | A soft contouring device intended to be attached to the eyepiece of a medical scope (e.g., endoscope, ophthalmoscope, microscope) to provide comfort for, or assist positioning of, the eye during use of the scope; it is not a storage cover. It may be in the form of a covering, brow rest, or eyecup and is typically intended for contact with a healthcare professional while performing a procedure, but some types are intended for contact with the patient while being viewed with an opthalmoscope; it does not include optics. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170063749 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]