Identity
- Trade Name
- Revolution FDA UDI
- Generic Name
- Orthopaedic cement/bone filler dispensing gun FDA UDI
- Device Name
- Cement Gun FDA UDI
- Model / Reference
- 0606600000 FDA UDI
- Description
- Cement Gun FDA UDI
Identifiers
- Catalog Number
- 0606-600-000 FDA UDI
- Primary DI / UDI-DI
- 04546540437037 FDA UDI
- FDA Product Code
- KIH FDA UDI
- GMDN Term
- Orthopaedic cement/bone filler dispensing gun FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement/bone filler dispensing gun
Revolution by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement/bone filler dispensing gun.
- Vertebroplasty Injector Kit — ADRIA SRL · Class I
- 2Mix Gun — Tecres · Class I
- Bone Cement Delivery Gun — Summit Medical, LLC · Class I
- Summit Medical Bone Cement Ratchet Delivery Gun — Summit Medical, LLC · Class I
- RALLY All In One Cement Gun — Tecres · Class I
- GUN-01 — Tecres · Class I
- ClearMix Vacuum Mixing System Bone Cement Delivery Gun — Summit Medical, LLC · Class I
- Prism II Ratchet Delivery Gun — Summit Medical, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 1f494b7c-57fa-462e-aff2-b21545add8ae 35 fields · synced Jun 8, 2026