FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SUCTION VALVE
DI: 04953170063428
·
Model: MAJ-207
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- SUCTION VALVE
- Primary DI
- 04953170063428
- Version / Model
- MAJ-207
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 8
- Public Version Date
- 2023-10-30
- Public Version Status
- Update
- Public Device Record Key
- fa832c58-924e-45f9-bd6e-77131afdadcf
- Distribution End Date
- 2022-04-01
Device Description
SUCTION VALVE MAJ-207
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
- ["Ethylene Oxide", "High-level Disinfectant", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGE | FORCEPS, BIOPSY, ELECTRIC | Gastroenterology, Urology | 876.4300 | 2 |
| FGA | Kit, nephroscope | Gastroenterology, Urology | 876.1500 | 2 |
| FAJ | Cystoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61793 | Endoscopic suction valve, reusable | A non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170063428 | GS1 | ||||
| Unit of Use | 84953170063424 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]