FDA UDI
In Commercial Distribution
🇺🇸 United States
MectaCem BonePrep
DI: 08031497002842
·
Model: 20.00003
·
TECRES SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MectaCem BonePrep
- Primary DI
- 08031497002842
- Version / Model
- 20.00003
- Company Name
- TECRES SPA
- Labeler DUNS
- 435428396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-17
- Public Version
- 1
- Public Version Date
- 2022-11-25
- Public Version Status
- New
- Public Device Record Key
- e370f17c-4e9a-4468-b22a-d3fe7e61133e
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | General, Plastic Surgery | 878.3300 | 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 | 08031497002842 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021765 | 000 |