FDA UDI
In Commercial Distribution
🇺🇸 United States
Vertecem II Cement Kit
DI: 04260056880759
·
Model: 08.702.017S
·
OSARTIS GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vertecem II Cement Kit
- Primary DI
- 04260056880759
- Version / Model
- 08.702.017S
- Catalog Number
- 08.702.017S
- Company Name
- OSARTIS GmbH
- Labeler DUNS
- 344261631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-21
- Public Version
- 5
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- c39685df-bd2f-4d59-a0b8-a22319c3f060
Device Description
Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure.
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 |
|---|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
| LOD | Bone Cement | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60505 | Vertebral bone filler, non-bioabsorbable | A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260056880759 | GS1 | ||||
| Package | 14260056880756 | GS1 | Shipping unit | 21 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 22 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 0°C (32°F) and 26°C (77°F)