FDA UDI
In Commercial Distribution
🇺🇸 United States
Dynasty
DI: M684DLXPGK541
·
Model: DLXPGK54
·
Microport Orthopedics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dynasty
- Primary DI
- M684DLXPGK541
- Version / Model
- DLXPGK54
- Catalog Number
- DLXPGK54
- Company Name
- Microport Orthopedics Inc.
- Labeler DUNS
- 079118736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d691a041-3b86-4b4b-8c56-a9e95243d2f0
Device Description
DYNASTY® A-CLASS® 54MM STD GROUP K CROSSLINKED POLY LINER
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
- Yes
- 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 |
|---|---|---|---|---|
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Orthopedic | 888.3320 | 3 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Orthopedic | 888.3330 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43168 | Non-constrained polyethylene acetabular liner | A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | DLXPGK54 | HIBCC | ||||
| Primary | M684DLXPGK541 | HIBCC |
Customer Contacts
- Phone
- 1-866-872-0211
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 54 | Millimeter |