INLET System Bone Screw

GUDID 08800089411580

Jeil Medical 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
Primary Device ID08800089411580
NIH Device Record Key1b2b0e4d-eac1-41ae-bb94-e0215695bc24
Commercial Distribution StatusIn Commercial Distribution
Brand NameINLET System Bone Screw
Version Model NumberIN40L-SA-052-TA
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
GS108800089411580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

[08800089411580]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-23
Device Publish Date2021-11-15

On-Brand Devices [INLET System Bone Screw]

08800089412129IN15L-HF-006
08800089412112IN15L-HF-007
08800089412105IN15L-HF-009
08800089412099IN15L-HF-011
08800089412082IN15L-HF-013
08800089412075IN15L-HF-014
08800089412068IN15L-HF-016
08800089412051IN15L-HF-018
08800089412044IN15L-HF-020
08800089412037IN20-HF-006
08800089412020IN20-HF-007
08800089412013IN20-HF-008
08800089412006IN20-HF-009
08800089411993IN20-HF-010
08800089411986IN20-HF-011
08800089411979IN20-HF-012
08800089411962IN20-HF-013
08800089411955IN20-HF-014
08800089411948IN20-HF-016
08800089411931IN20-HF-018
08800089411924IN20-HF-020
08800089411917IN20L-HF-006
08800089411900IN20L-HF-007
08800089411894IN20L-HF-008
08800089411887IN20L-HF-009
08800089411870IN20L-HF-010
08800089411863IN20L-HF-011
08800089411856IN20L-HF-012
08800089411849IN20L-HF-013
08800089411832IN20L-HF-014
08800089411825IN20L-HF-016
08800089411818IN20L-HF-018
08800089411801IN20L-HF-020
08800089411795IN15-HC-006
08800089411788IN15-HC-007
08800089411771IN15-HC-008
08800089411764IN15-HC-009
08800089411757IN15-HC-010
08800089411740IN15-HC-011
08800089411733IN15-HC-012
08800089411726IN15-HC-013
08800089411719IN15-HC-014
08800089411702IN15-HC-016
08800089411696IN15-HC-018
08800089411689IN15-HC-020
08800089411672IN18-HC-006
08800089411665IN18-HC-010
08800089411658IN23-FC-006
08800089411641IN23-FC-010
08800089411580IN40L-SA-052-TA
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