FDA UDI
In Commercial Distribution
🇺🇸 United States
EMPHASYS
DI: 10603295505563
·
Model: 4742-06-200
·
DEPUY (IRELAND)
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EMPHASYS
- Primary DI
- 10603295505563
- Version / Model
- 4742-06-200
- Catalog Number
- 474206200
- Company Name
- DEPUY (IRELAND)
- Labeler DUNS
- 989365556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-28
- Public Version
- 3
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- 09b62a5d-dfa1-4f84-b101-8d7c4446e7d3
Device Description
EMPHASYS 12/14 FEMORAL STEM COLLARED HIGH OFFSET HA COATED 6 HO
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented | Orthopedic | 888.3390 | 2 |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate | Orthopedic | 888.3353 | 2 |
| KWL | Prosthesis, hip, hemi-, femoral, metal | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64708 | Coated femoral stem prosthesis, one-piece | A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is 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 and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295505563 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]