Guided Growth Plate System DH0455CE

GUDID 18054242513209

Cannulated micro-ratcheting handle with QC connector

ORTHOFIX SRL

Surgical instrument handle, non-torque-limiting
Primary Device ID18054242513209
NIH Device Record Keyd99987e7-7fdb-4251-9553-40ceae0feb50
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Growth Plate System
Version Model Number1
Catalog NumberDH0455CE
Company DUNS438793622
Company NameORTHOFIX SRL
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242513209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2015-11-10

On-Brand Devices [Guided Growth Plate System]

18056099649674STERILIZATION BOX BASE
18054242518464GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L36MM D4.5MM STERILE
18054242518457GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L32MM D4.5MM STERILE
18054242518440GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L24MM D4.5MM STERILE
18054242518433GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L16MM D4.5MM STERILE
18054242518426GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L36MM D4.5MM STERILE
18054242518419GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L32MM D4.5MM STERILE
18054242518402GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L24MM D4.5MM STERILE
18054242518365GUIDED GROWTH PLATE SYSTEM PLUS TI QUAD PLATE L22MM STERILE
18054242518358GUIDED GROWTH PLATE SYSTEM PLUS TI QUAD PLATE L16MM STERILE
18054242518341GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L20MM STERILE
18054242518334GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L16MM STERILE
18054242518327GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L12MM STERILE
18054242518310GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L36MM D4.5MM
18054242518303GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L32MM D4.5MM
18054242518297GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L24MM D4.5MM
18054242518280GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L16MM D4.5MM
18054242518273GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L36MM D4.5MM
18054242518266GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L32MM D4.5MM
18054242518259GUIDED GROWTH PLATE SYSTEM PLUS TI SOLID SCREW L24MM D4.5MM
18054242518211GUIDED GROWTH PLATE SYSTEM PLUS TI QUAD PLATE L22MM
18054242518204GUIDED GROWTH PLATE SYSTEM PLUS TI QUAD PLATE L16MM
18054242518198GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L20MM
18054242518181GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L16MM
18054242518174GUIDED GROWTH PLATE SYSTEM PLUS TI EIGHT PLATE L12MM
18054242518150EXTENDED PLUS LINE CADDY EMPTY
18054242518143QUAD PLATE PLUS CADDY EMPTY
18054242518136EIGHT PLATE PLUS CADDY EMPTY
18054242518129STERILIZATION BOX LID
18054242518112STERILIZATION BOX COMPLETE
18054242518105STERILIZATION BOX EMPTY
18054242518099CANNULATED TAP D 3.5MM WITH QUICK CONNECT STERILE
18054242518082CANNULATED DRILL BIT D2.4MM WITH QUICK CONNECT STERILE
18054242518075CANNULATED DRILL BIT D3.2MM WITH QUICK CONNECT STERILE
18054242518068SELF-RETAINING CANNULATED SCREWDRIVER HEX3.5MM
18054242518051GUIDED GROWTH PLATE BENDER
18054242518044CANNULATED TAP D3.5MM WITH QUICK CONNECT
18054242518037CANNULATED DRILL BIT D2.4MM WITH QUICK CONNECT
18054242518020DRILL GUIDE
18054242513568Steribox guided growth stainless steel, complete
18054242513537Eight - plate, guided growth plate kit, 16 mm - 32 mm
18054242513520Eight - plate, guided growth plate kit, 12 mm - 24 mm
18054242513513Guided growth D.4.5 mm L.32 mm solid screw full thread, non sterile
18054242513506Guided growth D.4.5 mm L.24 mm solid ss screw full thread, non sterile
18054242513490Guided growth D.4.5 mm L.32 mm cannulated ss screw full thread, non sterile
18054242513483Guided growth D.4.5 mm L.24 mm cannulated ss screw full thread, non sterile
18054242513476Guided growth D.4.5 mm L.16 mm cannulated ss screw full thread, non sterile
18054242513469Eight - plate guided growth solid screw L.32 mm
18054242513452Eight - plate guided growth solid screw L.24 mm
18054242513445Eight - plate guided growth cannulated screw L.32 mm
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