FDA UDI
In Commercial Distribution
🇺🇸 United States
PRIME
DI: 00192629283541
·
Model: P3SAQB46
·
Microport Orthopedics Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PRIME
- Primary DI
- 00192629283541
- Version / Model
- P3SAQB46
- Catalog Number
- P3SAQB46
- Company Name
- Microport Orthopedics Inc.
- Labeler DUNS
- 079118736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-02
- Public Version
- 1
- Public Version Date
- 2021-09-10
- Public Version Status
- New
- Public Device Record Key
- b4aa6f8f-7913-4c33-9ed9-8496efda44d9
Device Description
PRIME AM QUAD SHELL 46 MM GROUP B
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 |
|---|---|---|---|---|
| OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented | Orthopedic | 888.3358 | 2 |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60516 | Metallic acetabulum prosthesis | A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M684P3SAQB461 | HIBCC | ||||
| Primary | 00192629283541 | GS1 |
Customer Contacts
- Phone
- +1(866)872-0211
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202705 | 000 |