INLET Foot 2.3 2.8 System Bone Plate

GUDID 08800089413232

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08800089413232
NIH Device Record Key481277b1-ae1b-47bb-9893-b1c0bb06181d
Commercial Distribution StatusIn Commercial Distribution
Brand NameINLET Foot 2.3 2.8 System Bone Plate
Version Model NumberINF23-LL-104-13
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
GS108800089413232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


[08800089413232]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-24
Device Publish Date2021-11-16

On-Brand Devices [INLET Foot 2.3 2.8 System Bone Plate]

08800089413287INF23-GR-006-13
08800089413270INF23-GR-008-13
08800089413263INF23-GR-009-13
08800089413256INF23-LL-004-13
08800089413249INF23-LL-005-13
08800089413232INF23-LL-104-13
08800089413225INF23-LL-105-13
08800089413218INF23-LL-204-13
08800089413201INF23-LL-205-13
08800089413195INF23-LL-304-13
08800089413188INF23-LL-305-13
08800089413171INF23-LR-004-13
08800089413164INF23-LR-005-13
08800089413157INF23-LR-104-13
08800089413140INF23-LR-105-13
08800089413133INF23-LR-204-13
08800089413126INF23-LR-205-13
08800089413119INF23-LR-304-13
08800089413102INF23-LR-305-13
08800089413096INF23-QL-006-13
08800089413089INF23-QL-008-13
08800089413072INF23-QR-006-13
08800089413065INF23-QR-008-13
08800089413058INF23-ST-002-13
08800089413041INF23-ST-004-13
08800089413034INF23-ST-005-13
08800089413027INF23-ST-006-13
08800089413010INF23-ST-102-13
08800089413003INF23-TL-004-13
08800089412990INF23-TL-005-13
08800089412983INF23-TR-004-13
08800089412976INF23-TR-005-13
08800089412969INF23-XL-004-13
08800089412952INF23-XL-104-13
08800089412945INF23-XL-204-13
08800089412938INF23-XR-004-13
08800089412921INF23-XR-104-13
08800089412914INF23-XR-204-13
08800089412907INF28-GR-006-16
08800089412891INF28-GR-008-16
08800089412884INF28-GR-009-16
08800089412877INF28-LL-004-16
08800089412860INF28-LL-005-16
08800089412853INF28-LL-104-16
08800089412846INF28-LL-105-16
08800089412839INF28-LL-204-16
08800089412822INF28-LL-205-16
08800089412815INF28-LL-304-16
08800089412808INF28-LL-305-16
08800089412792INF28-LR-004-16

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