GRAFTSITE

GUDID 15060238201145

GRAFTSITE Delivery Assistance Device

SUMMIT MEDICAL LIMITED

Anaesthesia conduction catheter
Primary Device ID15060238201145
NIH Device Record Key96c1922c-0c46-4a83-a55d-91173368d5ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRAFTSITE
Version Model NumberD201045
Company DUNS221751311
Company NameSUMMIT MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk

Device Identifiers

Device Issuing AgencyDevice ID
GS115060238201145 [Primary]
GS125060238201142 [Package]
Package: Cardboard Carton [5 Units]
In Commercial Distribution
GS135060238201149 [Package]
Contains: 25060238201142
Package: Box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAZAnesthesia Conduction Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-04
Device Publish Date2018-12-21

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25060238201364 - SmartMix™ Vacuum Syringe Plus2024-05-06 Bone cement mixing and delivery system
25060238201371 - SmartMix™ Delivery Gun2024-05-06 Bone Cement Delivery Gun
25060238201418 - SmartMix™ Syringe Kit2024-05-06 Bone cement delivery system
25060238201586 - SmartMix™ 9mm Narrow Nozzle2024-05-06 9mm Narrow Straight Nozzle
15060238200148 - SmartMix Vacuum Footpump and Airhose 2023-02-17 SmartMix Vacuum Footpump and Airhose

Trademark Results [GRAFTSITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GRAFTSITE
GRAFTSITE
88292982 not registered Live/Pending
Summit Medical Limited
2019-02-07

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