NA
- Primary DI
- B013DRUJSC10
- Brand
- NA
- Company
- APTIS MEDICAL, LLC
- Model
- DRUJ-SC10
- Catalog number
- DRUJ-SC10
- Device description
- 10 mm 3.5 Cortical Screw
- Published
- 2015-07-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- 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 |
|---|---|---|---|---|
| B013DRUJSC10 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic bone screw, non-bioabsorbable, sterile | A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Length | 10 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
| 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 |
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| 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 |
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| 00885556826249 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
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| 00885556826263 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | KXE | 2022-12-21 |
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| B013DRUJB10200 | NA | APTIS MEDICAL, LLC | KXE | 2021-08-27 |