n.a.
- Primary DI
- 04048551309452
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 28163FKD
- Device description
- Fixation handle f. dilation sleeves
- 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 |
|---|---|---|---|---|
| 04048551309452 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551309452 | 04048551309452 | 4048551309452 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical instrument handle, non-torque-limiting | A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10845854041116 | POWERPRO | Conmed Corporation | HRX | 2026-03-24 |
| 04056702011970 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702011987 | Autoclavable remote control | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702011994 | Double pedal foot switch | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012014 | Tube set for irrigation, single-use | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012038 | Tube set for suction, 2-lines, single-use | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012052 | Day use tube set for irrigation, pump part, 10 applications | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012076 | Patient tube for irrigation, single-use | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012090 | Tube set for vacuum, incl. filter, 30-day use | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012113 | Tube set for suction, single-use | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 04056702012137 | Tube set inflow 4-Spike adaptor | W.O.M. World of Medicine GmbH | HRX | 2026-03-10 |
| 00763000956028 | Tubing Set | MEDTRONIC XOMED, INC. | HRX | 2026-02-14 |
| B382SD401290 | Surgical Direct | Surgical Direct, Inc. | HRX | 2026-02-09 |
| B382SD401490 | Surgical Direct | Surgical Direct, Inc. | HRX | 2026-02-09 |
| 08031497003689 | Mendec® Kypho Set Monolateral 10 mm | TECRES SPA | HRX | 2025-12-17 |
| 08031497003696 | Mendec® Kypho Set Monolateral 15 mm | TECRES SPA | HRX | 2025-12-17 |
| 08031497003702 | Mendec® Kypho Set Monolateral 20 mm | TECRES SPA | HRX | 2025-12-17 |
| 08031497003801 | Mendec® Kypho Set Bilateral 10 mm | TECRES SPA | HRX | 2025-12-17 |
| 08031497003818 | Mendec® Kypho Set Bilateral 15 mm | TECRES SPA | HRX | 2025-12-17 |
| 08031497003825 | Mendec® Kypho Set Bilateral 20 mm | TECRES SPA | HRX | 2025-12-17 |
| 06938695521026 | Drill | Shanghai Kinetic Medical Co., Ltd. | HRX | 2025-12-09 |
| 08800038029323 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029330 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029347 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029354 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029361 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029378 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029415 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038029422 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |
| 08800038039407 | SteriSpine VA | IMEDICOM CO., LTD. | HRX | 2025-09-24 |