S-ROM
- Primary DI
- 10603295178255
- Brand
- S-ROM
- Company
- DEPUY ORTHOPAEDICS, INC.
- Model
- 56-3624
- Catalog number
- 563624
- Device description
- S-ROM Total Hip System FEMORAL STEM Standard 36 STD NECK +12 11/13 TAPER 24x19x175 Lateral
- Published
- 2015-03-24
- 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
Product Codes
| Code | Name |
|---|
| MRA | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10603295178255 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10603295178255 | 10603295178255 |
GMDN Terms
| Term | Definition |
|---|
| Uncoated hip femur prosthesis, modular | A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement. |
Regulatory Flags
- DUNS number
- 080506581
- 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
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 03596010194466 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-06 |
| 03596010194435 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-05 |
| 03596010194480 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-05 |
| 03596010194442 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-04 |
| 03596010194459 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-04 |
| 03596010194497 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-04 |
| 03596010194510 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-04 |
| 03596010194473 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-01 |
| 03596010194503 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-01 |
| 03596010194527 | SYNERGY | Smith & Nephew, Inc. | MRA | 2015-05-01 |
| 10603295000723 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000730 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000747 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000754 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000761 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000778 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000785 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000808 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000815 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000822 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295000839 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001027 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001034 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001041 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001058 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001065 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001072 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001089 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001096 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
| 10603295001102 | TRI-LOCK GRIPTION | DEPUY ORTHOPAEDICS, INC. | MRA | 2015-03-24 |
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