FDA UDI
Not in Commercial Distribution
🇺🇸 United States
UPGRADE KIT FOR UCES-3 (Version 4)
DI: 04953170335464
·
Model: MAJ-2051
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UPGRADE KIT FOR UCES-3 (Version 4)
- Primary DI
- 04953170335464
- Version / Model
- MAJ-2051
- 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
- 6
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- 9e72f0bf-97a4-40c4-920d-8613303fb377
- Distribution End Date
- 2022-02-21
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
| ODA | endoscopic central control unit | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58474 | Software upgrade/unlocking key | A software, hardware, or software/hardware combination device intended to be used to update/upgrade/unlock software embedded on a medical device through the use of an integral or separate media device (e.g., USB flash drive, CD). If supplied on a dedicated USB drive, it may be otherwise known as a ‘dongle’. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170335464 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]