FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SpaceFlex Hip Instrument Kit
DI: 08058964726186
·
Model: 900008
·
G21 SRL
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SpaceFlex Hip Instrument Kit
- Primary DI
- 08058964726186
- Version / Model
- 900008
- Company Name
- G21 SRL
- Labeler DUNS
- 431529195
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-04
- Public Version
- 1
- Public Version Date
- 2019-12-12
- Public Version Status
- New
- Public Device Record Key
- a7276257-b923-41b0-921b-e2a544441611
- Distribution End Date
- 2019-12-04
Device Description
SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MBB | Bone Cement, Antibiotic | Orthopedic | 888.3027 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | 888.3390 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45105 | Orthopaedic cement spacer mould | A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058964726186 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192041 | 000 |