Scopis
- Primary DI
- 07613327514179
- Brand
- Scopis
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 8000-021-002
- Catalog number
- 8000-021-002
- Device description
- ENT Software with TGS
- Published
- 2022-10-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| PGW | Ear, Nose, and Throat Stereotaxic Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07613327514179 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Stereotactic system application software | An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. |
Contacts
| Phone | Email |
|---|
| +0018002533210 | INST.STRYKER.CS@STRYKER.COM |
Regulatory Flags
- DUNS number
- 316153956
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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