FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniSight™
DI: 00889024596078
·
Model: OMST1065
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OmniSight™
- Primary DI
- 00889024596078
- Version / Model
- OMST1065
- Catalog Number
- OMST1065
- Company Name
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 137354267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-23
- Public Version
- 3
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 41b4aa1e-ec81-4b5b-97cb-957ffde282d2
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUG | Medical device data system | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64496 | Touchscreen | An electrically-powered visual display unit (VDU) designed as an output device for displaying data (e.g., patient images, videos) and as an input device to enable interactive manipulation of the data by the operator through touches to the display screen. It is intended to be connected to a computer or a medical device (i.e., the screen has no computing capabilities); it may be used to control a medical device (e.g., operating room lights) depending on parent device software. It is typically a portable or mounted liquid crystal display (LCD) or light-emitting diode (LED) unit, and may include an antimicrobial material to prevent cross-contamination in a medical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024596078 | GS1 |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 65.00 | Inch |