FDA UDI
In Commercial Distribution
🇺🇸 United States
Pressurizer
DI: 08053617184450
·
Model: Pressurizer
·
ADLER ORTHO SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pressurizer
- Primary DI
- 08053617184450
- Version / Model
- Pressurizer
- Catalog Number
- IZ03013
- Company Name
- ADLER ORTHO SPA
- Labeler DUNS
- 338847291
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- 4cf8e779-85d0-4aa3-bc4d-82e3088be59d
Device Description
PANTHEON PRESSURIZER STEM 13
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KIH | Dispenser, Cement | Orthopedic | 888.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46031 | Orthopaedic cement compressor | A device used to apply pressure to orthopaedic bone cement during a total hip arthroplasty (THA) procedure (within the acetabulum and/or femur) in order to optimise inner bone (cancellous) cement interdigitation to improve fixation of the implant. The device is typically made of a compressible silicone rubber which conforms to the shape of the cut bone to enable formation of a good seal. Cement may be injected through the device into the bone cavity using an appropriate syringe; pressure may be applied to the device with a firm handle (e.g., stainless steel), or a backplate. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08053617184450 | GS1 |