FDA UDI
In Commercial Distribution
🇺🇸 United States
OPERON
DI: 07613327170474
·
Model: OZ 7518475
·
STRYKER COMMUNICATIONS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OPERON
- Primary DI
- 07613327170474
- Version / Model
- OZ 7518475
- Catalog Number
- OZ 7518475
- Company Name
- STRYKER COMMUNICATIONS INC.
- Labeler DUNS
- 078807493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-24
- Public Version
- 1
- Public Version Date
- 2019-02-25
- Public Version Status
- New
- Public Device Record Key
- 0881f00d-d327-45e2-8fb5-6aa965db6093
Device Description
Surgical Table, D750 D850 XRAY CASSETTE TRAY
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GDC | TABLE, OPERATING-ROOM, ELECTRICAL | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14473 | X-ray film cassette holder | A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327170474 | GS1 |
Customer Contacts
- Phone
- +1(866)726-3705
- [email protected]