Dual Top Screw System / Dual Top Anchor System

GUDID 08806390805520

Jeil Medical Corporation

Orthodontic anchoring screw
Primary Device ID08806390805520
NIH Device Record Keyb5a7afef-499f-4bea-8266-eba7a6f8a60a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Top Screw System / Dual Top Anchor System
Version Model Number14-G2-008N
Company DUNS688811603
Company NameJeil Medical Corporation
Device Count2
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
GS108806390805520 [Primary]
GS108806390805896 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, Endosseous, Orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


[08806390805520]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-09-25
Device Publish Date2017-03-05

On-Brand Devices [Dual Top Screw System / Dual Top Anchor System]

0880928281963620-JB-010H
0880928281962920-JB-008H
08809282819537S20-JD-012
08809282819513S20-JD-008
08809282819483S20-JD-005
08809282819476S16-JD-012
08809282819469S16-JD-010
08809282819452S16-JD-008
08809282819391S14-JD-008
08809282819384S14-JD-007
08809282819353S20-G2-010N
08809282819322S20-G2-005N
08809282819278S16-G2-005N
08809282819261S14-G2-012N
08809282819254S14-G2-010N
08809282819230S14-G2-006N
08809282819223S14-G2-005N
08809282819216S20-JA-012N
08809282819193S20-JA-008N
08809282819186S20-JA-006N
08809282819162S16-JA-012N
08809282819148S16-JA-008N
08809282819124S16-JA-005N
08809282819117S14-JA-012N
08809282819094S14-JA-008N
08809282818714S20-JB-012H
08809282818097S16-JF-010
08809282816918S20-JA-012H
0880928281683320-LS-008
0880928281624616-JA-007H
08809282816215S25-JS-012
08809282816178S20-JS-012
0880928281613020-JO-010
0880928281607914-JO-006
0880928281605513-JO-006
0880928281602420-JK-006
0880928281601720-JK-005
0880928281599714-JK-008
0880928281598014-JK-006
0880928281596613-JK-006
0880928281593513-JD-008
0880928281592813-JD-006
0880928281590413-G2-006
0880928281589813-G1-008
0880928281588113-G1-006
0880928281587416-JB-005
08809282815768S14-JA-007H
08809282815249S14-MIM-008
08809282815218S20-JA-006H
08809282815157S16-JF-008

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