ENDOSPINE
- Primary DI
- 04048551234556
- Brand
- ENDOSPINE
- Company
- Karl Storz GmbH & Co. KG
- Model
- 28163DW
- Device description
- ENDOSPINE® Operating Tube
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| HRX | ARTHROSCOPE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551234556 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551234556 | 04048551234556 | 4048551234556 |
GMDN Terms
| Term | Definition |
|---|---|
| Spinal endoscopic-access system | An assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide |
Regulatory Flags
- DUNS number
- 315731430
- 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
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
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|---|---|---|---|---|
| 04048551232378 | n.a. | 27033U | 27033U | 2025-08-11 |
| 04048551232781 | n.a. | 27047B | 27047B | 2025-08-11 |
| 04048551418123 | n.a. | TC304US | TC304US | 2025-08-11 |
| 04048551210567 | n.a. | 8574GY | 8574GY | 2018-09-04 |
| 04048551210574 | n.a. | 8574GZ | 8574GZ | 2018-09-04 |
| 04048551211281 | n.a. | 8587K | 8587K | 2018-09-04 |
| 04048551211427 | n.a. | 8588K | 8588K | 2018-09-04 |
| 04048551211694 | n.a. | 8590KC | 8590KC | 2018-09-04 |
| 04048551425749 | n.a. | 40410LH | 40410LH | 2025-07-10 |
| 04048551425756 | n.a. | 40410LS | 40410LS | 2025-07-10 |
| 04048551425763 | n.a. | 40410LG | 40410LG | 2025-07-10 |
| 04048551425770 | n.a. | 40410LC | 40410LC | 2025-07-10 |
| 04048551425787 | n.a. | 40410LL | 40410LL | 2025-07-10 |
| 04048551425794 | n.a. | 40410LF | 40410LF | 2025-07-10 |
| 04048551425800 | n.a. | 40410LR | 40410LR | 2025-07-10 |
| 04048438008867 | NA | 051111-10 | 051111-10 | 2025-03-28 |
| 04048438008911 | NA | 051110-10 | 051110-10 | 2025-03-28 |
| 04048551010242 | NA | 497HCS | 497HCS | 2025-03-28 |
| 04048551012468 | NA | 11900RA | 11900RA | 2025-03-28 |
| 04048551061343 | NA | 20090331 | 20090331 | 2025-03-28 |
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