FDA UDI
In Commercial Distribution
🇺🇸 United States
Revolution
DI: 07613154169696
·
Model: 0606595000
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Revolution
- Primary DI
- 07613154169696
- Version / Model
- 0606595000
- Catalog Number
- 0606-595-000
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 3
- Public Version Date
- 2025-12-31
- Public Version Status
- Update
- Public Device Record Key
- afcc1726-1551-4e39-9fbb-6026b3c6eb85
Device Description
Cement Mixing System with MIS Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (Medium)
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 |
|---|---|---|---|---|
| JDZ | MIXER, CEMENT, FOR CLINICAL USE | Orthopedic | 888.4210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47737 | Orthopaedic cement injection cannula | A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613154169697 | GS1 | pack | 6 | In Commercial Distribution | |
| Primary | 07613154169696 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]