Dyna Locking Trochanteric Nail™

GUDID 08800037551504

U&I CORPORATION

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08800037551504
NIH Device Record Key374bde52-3d4d-4d3d-85b5-ff0310ef3ce2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyna Locking Trochanteric Nail™
Version Model Number35002
Company DUNS688811082
Company NameU&I CORPORATION
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800037551504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


[08800037551504]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-16

On-Brand Devices [Dyna Locking Trochanteric Nail™]

08800015940665NG2225
08800015940658NG2220
08800015940641NG2215
08800015940634NG2210
08800015940627NG2205
08800015940610NG2200
08800015940603NG2195
08800015940597NG2190
08800015940580NG2185
08800015940573NG2180
08800015940566NG2175
08800015940559NG2170
08800015940542NG2125
08800015940535NG2120
08800015940528NG2115
08800015940511NG2110
08800015940504NG2105
08800015940498NG2100
08800015940481NG2095
08800015940474NG2090
08800015940467NG2085
08800015940450NG2080
08800015940443NG2075
08800015940436NG2070
08800015940429NG141246R
08800015940412NG141246L
08800015940405NG141244R
08800015940399NG141244L
08800015940382NG141242R
08800015940375NG141242L
08800015940368NG141240R
08800015940351NG141240L
08800015940344NG141238R
08800015940337NG141238L
08800015940320NG141236R
08800015940313NG141236L
08800015940306NG141234R
08800015940290NG141234L
08800015940283NG141232R
08800015940276NG141232L
08800015940269NG141146R
08800015940252NG141146L
08800015940245NG141144R
08800015940238NG141144L
08800015940221NG141142R
08800015940214NG141142L
08800015940207NG141140R
08800015940191NG141140L
08800015940184NG141138R
08800015940177NG141138L

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