FDA UDI
In Commercial Distribution
🇺🇸 United States
PALAMIX®
DI: 04260102132375
·
Model: Nozzle Medium
·
Heraeus Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PALAMIX®
- Primary DI
- 04260102132375
- Version / Model
- Nozzle Medium
- Catalog Number
- 66043960
- Company Name
- Heraeus Medical GmbH
- Labeler DUNS
- 333623937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-16
- Public Version
- 4
- Public Version Date
- 2019-05-13
- Public Version Status
- Update
- Public Device Record Key
- 4ebbc4fd-546f-4f2c-91a3-29ee6c125883
Device Description
PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-mixed by the PALAMIX® uno or PALAMIX® duo vacuum mixing system. PALAMIX® nozzle medium is the accessory of PALAMIX® uno or PALAMIX® duo vacuum mixing system intended for use in placing bone cement into surgical sites.
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
- Yes
- 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 |
|---|---|---|---|---|
| KIH | Dispenser, Cement | Orthopedic | 888.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35809 | Orthopaedic cement dispenser | A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260102132375 | GS1 | ||||
| Package | 04260102132382 | GS1 | 10 | In Commercial Distribution | ||
| Package | 04260102132320 | GS1 | Palette | 500 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius