n.a.
- Primary DI
- 04048551288764
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 28163SIU
- Device description
- Suction-Irrigation Unit
- 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 |
|---|---|
| GCJ | Laparoscope, general & plastic surgery |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551288764 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551288764 | 04048551288764 | 4048551288764 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical irrigation/aspiration handpiece control valve | A sterile device designed as a push-button valve that is inserted into the control valve seat of a reusable surgical irrigation/aspiration handpiece and when activated by the operator will interrupt the aspiration (suction) and activate the irrigation function (the fluid flow) of the handpiece/system. This provides a high level of hygiene as this device is removed after each application and discarded negating complicated and time-consuming cleaning procedures. This is a single-use 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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|---|---|---|---|---|
| 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 |
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