FDA UDI
In Commercial Distribution
🇺🇸 United States
CEMEX SYSTEM FAST 40G
DI: 28031497001399
·
Model: 13A2020
·
TECRES SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEMEX SYSTEM FAST 40G
- Primary DI
- 28031497001399
- Version / Model
- 13A2020
- Company Name
- TECRES SPA
- Labeler DUNS
- 435428396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 955a53c0-9e52-45b9-9ccd-776038ea33a3
Device Description
Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast setting. Cemex System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex System Fast 40g is indicated for the fixation of joint prosthesis implants to the host bone.
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 |
|---|---|---|---|---|
| LOD | Bone Cement | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45253 | Orthopaedic cement preparation/delivery kit | A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 28031497001399 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031430 | 000 |