Identity
- Trade Name
- Prism II Ratchet Delivery Gun FDA UDI
- Generic Name
- Orthopaedic cement/bone filler dispensing gun FDA UDI
- Device Name
- Prism II Ratchet Delivery Gun FDA UDI
- Model / Reference
- 5401-35-000 FDA UDI
- Description
- Prism II Ratchet Delivery Gun FDA UDI
Identifiers
- Catalog Number
- 5401-35-000 FDA UDI
- Primary DI / UDI-DI
- 15060238200155 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic cement/bone filler dispensing gun FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement/bone filler dispensing gun
Prism II Ratchet Delivery Gun by Summit Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (1)
- FDA UDI bced124a-6f5d-42ca-8b78-23f8beb07b38 35 fields · synced May 30, 2026