Dual Top Screw System

GUDID 08806390876926

Jeil Medical Corporation

Orthodontic anchoring screw
Primary Device ID08806390876926
NIH Device Record Key489a500a-d594-4a6d-9e33-6164e3eb42a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Top Screw System
Version Model NumberS13-JK-008
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806390876926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, Endosseous, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-19
Device Publish Date2022-01-11

On-Brand Devices [Dual Top Screw System]

08806390899833S13-JK-006
08806390891622S20-JK-008
08806390880473S13-JO-008
08806390876926S13-JK-008
08800089427130S20-JO-012
08800089427123S20-JO-010
08800089427116S20-JO-008
08800089427109S20-JO-007
08800089427093S20-JO-006
08800089427086S20-JO-005
08800089427079S20-JK-012
08800089427062S20-JK-007
08800089427055S16-MIM-007
08800089427048S16-JO-012
08800089427031S16-JO-007
08800089427024S16-JO-005
08800089427017S16-JK-012
08800089427000S16-JK-007
08800089426997S14-MIM-007
08800089426980S14-JO-012
08800089426973S14-JO-010
08800089426966S14-JO-008
08800089426959S14-JO-007
08800089426942S14-JO-006
08800089426935S14-JO-005
08800089426928S14-JK-012
08800089426911S14-JK-007
08800089426904S14-JK-005
08800089426898S13-JO-007
08800089426881S13-JO-006
08800089426874S13-JO-005
08800089426867S13-JK-007
08800089426850S13-JK-005
0880008942684320-JO-012
0880008942683620-JO-007
0880008942682920-JK-012
0880008942681220-JK-007
0880008942680516-MIM-007
0880008942679916-JO-012
0880008942678216-JO-007
0880008942677516-JK-012
0880008942676816-JK-007
0880008942675114-MIM-007
0880008942674414-JO-012
0880008942673714-JO-010
0880008942672014-JO-007
0880008942671314-JO-005
0880008942670614-JK-012
0880008942669014-JK-010
0880008942668314-JK-007

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.