FDA UDI
In Commercial Distribution
🇺🇸 United States
OTV-S500 UPGRADE PACK STROBE
DI: 04953170458170
·
Model: MAJ-2547
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OTV-S500 UPGRADE PACK STROBE
- Primary DI
- 04953170458170
- Version / Model
- MAJ-2547
- Catalog Number
- N6216940
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-17
- Public Version
- 1
- Public Version Date
- 2025-03-25
- Public Version Status
- New
- Public Device Record Key
- 02a93446-9739-4058-bb41-66b43cf29607
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 |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Gastroenterology, Urology | 876.1500 | 2 |
| EQL | Laryngostroboscope | Ear, Nose, Throat | 874.4750 | 1 |
| NTN | Led Light Source | Gastroenterology, Urology | 876.1500 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 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 | 04953170458170 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243380 | 000 |