FDA.reportPublic FDA data

SmartMix™ Delivery Gun

Primary DI
15060238201374
Brand
SmartMix™ Delivery Gun
Company
SUMMIT MEDICAL LIMITED
Model
5401-76-513
Catalog number
5401-76-513
Device description
Bone Cement Delivery Gun
Published
2024-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060238201371PackageGS11In Commercial Distribution
15060238201374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506023820137125060238201371
1506023820137415060238201374

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusableA hand-operated device designed to hold an orthopaedic cartridge/syringe filled with orthopaedic cement and/or a bone void filling material (not included) to facilitate the dispensing of the substance to the application site or an application device; it is not designed to prepare/mix the substance. Also known as a cement gun, it is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441451821311info@summit-medical.co.uk

Regulatory Flags#

DUNS number
221751311
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060238200155Prism II Ratchet Delivery Gun5401-35-0005401-35-0002022-12-09
15060238200162SmartMix Tower - Cement Delivery Gun5401-97-0005401-97-0002022-12-09
15060238200377Summit Medical Bone Cement Delivery GunH719H7192022-12-09
15060238200742MiniMix LVSMLVSMLV2019-10-30
15060238200759MiniMix™ Delivery SyringeSMDS1C2021-12-01
15060238200995ClearMix Vacuum Mixing System Bone Cement Delivery Gun4147004147002022-12-09
15060238201787MiniMix™SMMM1SMMM12025-01-10
15060238201794MiniMix™ LVSMLVSMLV2025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201817Bone Cement Delivery GunH759H7592025-01-10
15060238201824Bone Cement Delivery GunH759LH759L2025-01-10
15060238201848Bone Cement Delivery GunH719H7192025-01-10
15060238200148SmartMix Vacuum Footpump and Airhose5401-96-5002023-02-09
15060238200254Summit Medical Bone Cement Ratchet Delivery GunH759H7592023-02-09
15060238200261Summit Medical Bone Cement Ratchet Delivery GunH759LH759L2023-02-09
15060238200278Summit Medical High Vacuum Footpump + Air HoseH550H5502023-02-09
15060238200452SmartMix CemVac Dual Vacuum Footpump & Airhose321002632100262023-02-09
15060238200735MiniMix™ Bone Cement/Substitute Mixing SystemSMMM1N/A2021-12-01
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18

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00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
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