FDA UDI
In Commercial Distribution
🇺🇸 United States
RECIVER DISH
DI: 04953170305689
·
Model: MAJ-1868
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RECIVER DISH
- Primary DI
- 04953170305689
- Version / Model
- MAJ-1868
- 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
- 6
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- 12e041cd-3d85-43a3-93b4-69534267d373
Device Description
MAJ-1868 ScopeGuide Receiver Dish
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FDF | Colonoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64660 | Gastrointestinal catheter/endoscope tracking system sensor, bedside | An external, electrically-powered component of a gastrointestinal catheter/endoscope tracking system designed to receive and process electromagnetic (EM) field data produced by an appropriate catheter/endoscope in situ for real-time visualization of the catheter/endoscope position within the gastrointestinal tract. It is typically a flat panel designed to be mounted next to the patient to transcutaneously receive the specific EM pulses generated by the catheter/endoscope and transmit the data to an appropriate processing unit/monitor (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170305689 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]