n.a.
- Primary DI
- 04048551110225
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 28205GDS
- Device description
- Finish Barrel Burr, sterile, 6x
- Published
- 2018-08-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|---|---|---|---|
| 04048551110225 | Primary | GS1 | 0 | |
| 04048551241905 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551110225 | 04048551110225 | 4048551110225 |
| 04048551241905 | 04048551241905 | 4048551241905 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic bur, single-use | A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 315731430
- Device count
- 6
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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 |
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|---|---|---|---|---|
| 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 |