FDA UDI
In Commercial Distribution
🇺🇸 United States
KEYBOARD
DI: 04953170343384
·
Model: MAJ-1995
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KEYBOARD
- Primary DI
- 04953170343384
- Version / Model
- MAJ-1995
- Catalog Number
- N4505930
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-17
- Public Version
- 3
- Public Version Date
- 2023-12-27
- Public Version Status
- Update
- Public Device Record Key
- c1395f5b-f36e-44c7-a908-3f80a5be2079
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 |
|---|---|---|---|---|
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62940 | Computer/medical device keyboard | A desktop, electronic component of a computer/medical device intended to operate and/or control the use of the parent device. It has a panel of keys, including alpha-numeric characters, and may have touchscreen capability and/or specialized keys to control specialized functionality of the parent device. It is not dedicated to those with a disability. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170343384 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]