Summa Orthopaedics Wrist System Bone Plate

GUDID 08806390886048

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08806390886048
NIH Device Record Keyf2d8a5d0-b420-4c9a-ad43-2e66a32ebc66
Commercial Distribution StatusIn Commercial Distribution
Brand NameSumma Orthopaedics Wrist System Bone Plate
Version Model NumberSO-25R-DVRA-209-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
GS108806390886048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390886048]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-24
Device Publish Date2020-04-16

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
08806390868013SO-25-CAFU-006
08806390868006SO-25-CAFU-007
08806390862479SO-25V-DLUL-107-H3
08806390862462SO-25V-DLUL-107-H2
08806390862455SO-25V-DLUL-106-H2
08806390862448SO-25V-DLUL-007-H3
08806390862431SO-25V-DLUL-007-H2
08806390862424SO-25V-DLUL-006-H2

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