FDA UDI
In Commercial Distribution
🇺🇸 United States
BALLOON
DI: 04953170360459
·
Model: MAJ-1351
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- BALLOON
- Primary DI
- 04953170360459
- Version / Model
- MAJ-1351
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- fc26c20e-0a8c-4416-95ca-98ebdc25b8d3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDS | Gastroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| ODG | Endoscopic ultrasound system, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61506 | Ultrasound endoscope balloon, Hevea-latex | A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170360459 | GS1 | ||||
| Unit of Use | 84953170360455 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]