FDA UDI
In Commercial Distribution
🇺🇸 United States
Bespoke
DI: E314HPCCO0100010
·
Model: HPC-CO01-00-01
·
MATERIALISE USA, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bespoke
- Primary DI
- E314HPCCO0100010
- Version / Model
- HPC-CO01-00-01
- Catalog Number
- HPC-CO01-00-01
- Company Name
- MATERIALISE USA, L.L.C.
- Labeler DUNS
- 946657160
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-21
- Public Version
- 4
- Public Version Date
- 2019-11-27
- Public Version Status
- Update
- Public Device Record Key
- 29ba6aa9-299c-4caf-8593-9960408d50ff
Device Description
Consensus CT THA guides and bone models
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| PLW | Acetabular Cup Orientation System | Orthopedic | 888.3350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62249 | Custom-made organ/bone anatomy model/surgical guide kit | A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | E314HPCCO010001 | HIBCC | ||||
| Primary | E314HPCCO0100010 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150780 | 000 |