Identity
- Trade Name
- PALAGUN® FDA UDI
- Generic Name
- Orthopaedic cement/bone filler dispensing gun FDA UDI
- Device Name
- PALAGUN® Bone Cement Mixing System - Disposable Cement Gun [Model NO.:CL006-02] FDA UDI
- Model / Reference
- CL006-02E(CM194) FDA UDI
- Description
- PALAGUN® Bone Cement Mixing System - Disposable Cement Gun [Model NO.:CL006-02] FDA UDI
Identifiers
- Catalog Number
- CL006-02E(CM194) FDA UDI
- Primary DI / UDI-DI
- 06951233720842 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement/bone filler dispensing gun
Palagun® by Guangzhou Clean Medical Products Manufacturing 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
- RMA Revolution — Stryker Corp. · Class II
- Revolution — Stryker Corp. · 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
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
- Guangzhou Clean Medical Products Manufacturing Corp.
Sources (1)
- FDA UDI 9c3f7420-f970-4f41-a391-2db14d1ede4e 34 fields · synced Jun 8, 2026