FDA UDI
In Commercial Distribution
🇺🇸 United States
S-ROM ZTT
DI: 10603295175643
·
Model: 55-0748
·
DEPUY ORTHOPAEDICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- S-ROM ZTT
- Primary DI
- 10603295175643
- Version / Model
- 55-0748
- Catalog Number
- 550748
- Company Name
- DEPUY ORTHOPAEDICS, INC.
- Labeler DUNS
- 080506581
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-24
- Public Version
- 4
- Public Version Date
- 2022-12-05
- Public Version Status
- Update
- Public Device Record Key
- 710f724a-10ba-444f-863f-057fcba17f16
Device Description
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 24 F LRG FITS: 22 x 17 STEM Cone: F Triangle: LRG 22 INTERNAL DIAMETER
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRA | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented | Unknown | 3 | |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61556 | Sleeve femoral/tibial extension, coated | A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295175643 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]