Summa Orthopaedics System Surgical Instrument

GUDID 08806390869454

Jeil Medical Corporation

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID08806390869454
NIH Device Record Keyf6b81999-bd57-4e82-b303-965d0c0edbcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSumma Orthopaedics System Surgical Instrument
Version Model NumberSO-111-082-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 Usefalse
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
GS108806390869454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390869454]

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 System Surgical Instrument]

08806390883702SO-112-120
08806390883696SO-111-067-5
08806390883689SO-111-068-5
08806390883672SO-113-HF-617
08806390883665SO-111-098
08806390883658SO-112-40-701
08806390876155SO-111-260
08806390869027SO-111-047
08806390868983SO-111-125
08806390868976SO-111-124
08806390868952SO-111-046
08806390868044SO-111-080
08806390865852SO-111-059
08806390865845SO-111-058
08806390865791SO-111-068-4
08806390865296SO-111-057
08806390865272SO-111-068-2
08806390864084SO-111-056
08806390864077SO-111-055
08806390864060SO-111-060
08806390863292SO-111-100
08806390863285SO-111-096
08806390863278SO-111-089
08806390863254SO-111-087
08806390863230SO-111-068-3
08806390862677SO-111-104-R2
08806390862660SO-111-104-R
08806390862653SO-111-104-L2
08806390862646SO-111-104-L
08806390862615SO-111-127
08806390886130SO-112-129-7
08806390886123SO-112-129-6
08806390886116SO-112-129-5
08806390886109SO-112-129-4
08806390886093SO-112-129-3
08806390886086SO-112-129
08806390885799SO-111-230-R
08806390885782SO-111-230-L
08806390885775SO-111-229-R
08806390885768SO-111-229-L
08806390885751SO-111-228-R
08806390885744SO-111-228-L
08806390885737SO-111-227-R
08806390885720SO-111-227-L
08806390885713SO-111-226
08806390869492SO-111-095-L
08806390869485SO-111-095-R
08806390869478SO-111-083-L
08806390869461SO-111-083-R
08806390869454SO-111-082-L

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