Identity
- Trade Name
- GUN-01 FDA UDI
- Generic Name
- Orthopaedic cement/bone filler dispensing gun FDA UDI
- Device Name
- GUN-01 is intended to be used for helping the extrusion (and hence the delivery) of bone cement only from the Tecres’ syringes Cemex System Device. FDA UDI
- Model / Reference
- GUN-01 FDA UDI
- Description
- GUN-01 is intended to be used for helping the extrusion (and hence the delivery) of bone cement only from the Tecres’ syringes Cemex System Device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497002187 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement/bone filler dispensing gun
Gun-01 by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement/bone filler dispensing gun.
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- Prism II Ratchet Delivery Gun — Summit Medical, LLC · Class I
- Bone Cement 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 |
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Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI 4792e870-5023-4656-9669-be2a5875bbc4 33 fields · synced Jun 1, 2026