YomiLink Arch (LLUR)

GUDID 00810004900523

YomiLink Arch (LLUR)

NEOCIS INC

Dental stereotactic surgery system
Primary Device ID00810004900523
NIH Device Record Keyd14e6c23-8576-4684-a4b7-40224425350e
Commercial Distribution StatusIn Commercial Distribution
Brand NameYomiLink Arch (LLUR)
Version Model NumberDRW-2208-01
Company DUNS802312434
Company NameNEOCIS INC
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 Datefalse
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
GS100810004900523 [Primary]

FDA Product Code

PLVDental Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


[00810004900523]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-24
Device Publish Date2023-08-16

Devices Manufactured by NEOCIS INC

00810004900394 - Neocis Guidance System2024-07-29 TrackerNeo Draping Kit
00810004900608 - YomiLink Teeth Posterior (LRUL)2024-05-27 YomiLink Teeth Posterior (LRUL)
00810004900615 - YomiLink Teeth Posterior (LLUR)2024-05-27 YomiLink Teeth Posterior (LLUR)
00810004900523 - YomiLink Arch (LLUR)2023-08-24YomiLink Arch (LLUR)
00810004900523 - YomiLink Arch (LLUR)2023-08-24 YomiLink Arch (LLUR)
00810004900530 - YomiLink Arch (LRUL)2023-08-24 YomiLink Arch (LRUL)
00810004900547 - YLA Probing Bit - Contra Angle2023-08-24 YLA Probing Bit - Contra Angle
00810004900554 - YLA Probing Bit - Straight2023-08-24 YLA Probing Bit - Straight
00810004900486 - YomiLink Bone (UL)2023-03-01 YomiLink Bone (UL)

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