n.a.
- Primary DI
- 04048551094624
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 28133CR
- Device description
- Arthroscope Sheath
- 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 |
|---|---|---|---|---|
| 04048551094624 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551094624 | 04048551094624 | 4048551094624 |
GMDN Terms
| Term | Definition |
|---|---|
| Endoscope sheath, reusable | A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
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
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| 04048551210574 | n.a. | 8574GZ | 8574GZ | 2018-09-04 |
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| 04048551211427 | n.a. | 8588K | 8588K | 2018-09-04 |
| 04048551211694 | n.a. | 8590KC | 8590KC | 2018-09-04 |
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| 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 |
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