FDA UDI
In Commercial Distribution
🇺🇸 United States
Y/C cable
DI: 04953170026669
·
Model: MB-631
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Y/C cable
- Primary DI
- 04953170026669
- Version / Model
- MB-631
- Catalog Number
- 2285113
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 8
- Public Version Date
- 2023-06-16
- Public Version Status
- Update
- Public Device Record Key
- b8aa9509-8e3e-4634-b472-8b9da6f75cf8
Device Description
"MB-631 ISOLATION TRANSFORMER"
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
- No
- PM Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCW | Transformer, Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36800 | Isolation transformer | A device designed to be used in a mains electricity alternating current (AC) circuit to increase (step-up) or decrease (step-down) voltage, to provide the specified voltage to a parent device; it is not a built-in component of the parent device. It provides isolation between the mains current and the parent device for safety, and has separate primary (input) and secondary (output) coils. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170026669 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]