FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Water-resistant Cap
DI: 04953170153891
·
Model: MAJ-1195
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Water-resistant Cap
- Primary DI
- 04953170153891
- Version / Model
- MAJ-1195
- 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
- 2016-09-21
- Public Version
- 9
- Public Version Date
- 2022-06-30
- Public Version Status
- Update
- Public Device Record Key
- 9122c3fe-2275-4c17-810e-1f99a328e094
- Distribution End Date
- 2022-06-29
Device Description
MAJ-1195 Water resistant cap for AT8 EUS
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["High-level Disinfectant", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODG | Endoscopic ultrasound system, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
| FET | Endoscopic video imaging system/component, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
| FDS | Gastroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61723 | Luminal device flushing tubing set, reusable | A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170153891 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]