NA
- Primary DI
- B013DRUJP20
- Brand
- NA
- Company
- APTIS MEDICAL, LLC
- Model
- DRUJ-P20
- Catalog number
- DRUJ-P20
- Device description
- Distal Radio-Ulnar Joint Plate Assembly, Size 20
- Published
- 2015-06-02
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| KXE | Prosthesis, Wrist, Hemi-, Ulnar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B013DRUJP20 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Wrist ulna-head prosthesis | A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide |
Regulatory Flags
- DUNS number
- 780455338
- 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
- true
- 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 |
|---|---|---|---|---|
| B013DRUJKW450 | Scheker DRUJ | DRUJ-KW45 | DRUJ-KW54 | 2023-06-08 |
| B013DRUJLDG250 | Scheker Prosthesis | DRUJ-LDG25 | 2019-05-14 | |
| B013DRUJKW540 | Scheker DRUJ | DRUJ-KW54 | DRUJ-KW54 | 2021-11-26 |
| B013DRUJKWD0 | Scheker DRUJ | DRUJ-KWD | DRUJ-KWD | 2021-11-26 |
| B013MITDRUJ1000 | Scheker DRUJ | MITDRUJ-100 | MITDRUJ-100 | 2021-11-26 |
| B013MITINT1000 | Scheker DRUJ | MITINT-100 | MITINT-100 | 2021-11-26 |
| B013DRUJB10200 | NA | DRUJ-B1020 | DRUJ-B1020 | 2021-08-27 |
| B013DRUJB200 | NA | DRUJ-B20 | DRUJ-B20 | 2021-08-27 |
| B013DRUJB300 | NA | DRUJ-B30 | DRUJ-B30 | 2021-08-27 |
| B013DRUJIS0450 | NA | DRUJ-IS045 | DRUJ-IS045 | 2021-08-27 |
| B013DRUJIS0500 | NA | DRUJ-IS050 | DRUJ-IS050 | 2021-08-27 |
| B013DRUJIS1400 | NA | DRUJ-IS140 | DRUJ-IS140 | 2021-08-27 |
| B013DRUJIS1450 | NA | DRUJ-IS145 | DRUJ-IS145 | 2021-08-27 |
| B013DRUJIS1500 | NA | DRUJ-IS150 | DRUJ-IS150 | 2021-08-27 |
| B013DRUJIS1600 | NA | DRUJ-IS160 | DRUJ-160 | 2021-08-27 |
| B013DRUJIS2400 | NA | DRUJ-IS240 | DRUJ-IS240 | 2021-08-27 |
| B013DRUJIS2450 | NA | DRUJ-IS245 | DRUJ-IS245 | 2021-08-27 |
| B013DRUJIS2500 | NA | DRUJ-IS250 | DRUJ-IS250 | 2021-08-27 |
| B013DRUJIS2600 | NA | DRUJ-IS260 | DRUJ-IS260 | 2021-08-27 |
| B013DRUJIS3400 | NA | DRUJ-IS340 | DRUJ-IS340 | 2021-08-27 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00885556826621 | First Choice DRUJ and MUH | Smith & Nephew, Inc. | KXE | 2023-06-16 |
| 00885556826461 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826478 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826485 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826492 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826508 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826515 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826522 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826539 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826546 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826553 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826560 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826577 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826584 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826591 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826607 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826614 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826195 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826201 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826218 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826225 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826232 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826249 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826256 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826263 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826270 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826287 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826294 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| 00885556826300 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
| B013DRUJB10200 | NA | APTIS MEDICAL, LLC | KXE | 2021-08-27 |