Summa Orthopaedics Wrist System Bone Plate

GUDID 08806390869416

Jeil Medical Corporation

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID08806390869416
NIH Device Record Keyabeb0d7a-8efa-4da9-8e93-dd10c2663170
Commercial Distribution StatusIn Commercial Distribution
Brand NameSumma Orthopaedics Wrist System Bone Plate
Version Model NumberSO-25-DVRA-309-L
Company DUNS688811603
Company NameJeil Medical Corporation
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 Datetrue
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
GS108806390869416 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390869416]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-11
Device Publish Date2018-04-30

On-Brand Devices [Summa Orthopaedics Wrist System Bone Plate]

08806390876988SO-25-DVRA-310-L
08806390876971SO-25-DVRA-310-R
08806390876964SO-25-DVRA-210-L
08806390876957SO-25-DVRA-210-R
08806390876940SO-25-DVRA-110-L
08806390876933SO-25-DVRA-110-R
08806390869430SO-25-DVRA-311-L
08806390869423SO-25-DVRA-311-R
08806390869416SO-25-DVRA-309-L
08806390869409SO-25-DVRA-309-R
08806390869393SO-25-DVRA-211-L
08806390869386SO-25-DVRA-211-R
08806390869379SO-25-DVRA-209-L
08806390869362SO-25-DVRA-209-R
08806390869355SO-25-DVRA-111-L
08806390869348SO-25-DVRA-111-R
08806390869331SO-25-DVRA-109-L
08806390869324SO-25-DVRA-109-R
08806390886079SO-25R-DVRA-211-R
08806390886062SO-25R-DVRA-211-L
08806390886055SO-25R-DVRA-209-R
08806390886048SO-25R-DVRA-209-L
08806390886031SO-25R-DVRA-110-R
08806390886024SO-25R-DVRA-110-L
08806390886017SO-25R-DVRA-108-R
08806390886000SO-25R-DVRA-108-L
08806390885881SO-25J-DVRA-211-R
08806390885874SO-25J-DVRA-211-L
08806390885867SO-25J-DVRA-209-R
08806390885850SO-25J-DVRA-209-L
08806390885843SO-25J-DVRA-110-R
08806390885836SO-25J-DVRA-110-L
08806390885829SO-25J-DVRA-108-R
08806390885812SO-25J-DVRA-108-L

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