FDA.reportPublic FDA data

Neocis Guidance System

Primary DI
00810004900622
Brand
Neocis Guidance System
Company
NEOCIS INC
Model
DRW-0735-12
Device description
Instrumentarium OP 300 Chin Rest-DRW-0735-12
Published
2025-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IWYHolder, Head, Radiographic
QRYDental Navigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1
QRYDental Navigation SystemDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810004900622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004900622008100049006228100049006220810004900622

GMDN Terms#

Term, Definition table
TermDefinition
Dental stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
802312434
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810004900851O Rings for Yomi S TEE Screw Bag of 25DRW-3848-002026-06-03
00810004900639Yomi S Extra Oral Fiducial Array LLURDRW-2824-012025-12-01
00810004900646Yomi S Extra Oral Fiducial Array LRULDRW-2824-022025-12-01
00810004900653Yomi S Intra Oral Fiducial Array SmallDRW-2823-012025-12-01
00810004900660Yomi S Intra Oral Fiducial Array MediumDRW-2823-022025-12-01
00810004900677Yomi S Intra Oral Fiducial Array LargeDRW-2823-032025-12-01
00810004900684Yomi S YomiLink Teeth Posterior LLURDRW-2773-012025-12-01
00810004900691Yomi S YomiLink Teeth Posterior LRULDRW-2773-022025-12-01
00810004900707Yomi S YomiLink Arch LLURDRW-2774-012025-12-01
00810004900714Yomi S YomiLink Arch LRULDRW-2774-022025-12-01
00810004900721Yomi S YomiLink Teeth Anterior LLURDRW-2775-012025-12-01
00810004900738Yomi S YomiLink Teeth Anterior LRULDRW-2775-022025-12-01
00810004900745Yomi S YomiLink Bone Lower LLDRW-2771-012025-12-01
00810004900752Yomi S YomiLink Bone Lower LRDRW-2771-022025-12-01
00810004900769Yomi S YomiLink Bone Upper ULDRW-2772-012025-12-01
00810004900776Yomi S YomiLink Bone (U) Assembly (UR)DRW-2772-022025-12-01
00810004900783Yomi S Tracker End Effector AssemblyDRW-2839-002025-12-01
00810004900790Yomi S YomiLink-TEE ScrewDRW-2682-002025-12-01
00810004900806Yomi S TEE Flange ScrewDRW-2683-002025-12-01
00810004900813Yomi S Fiducial Array ScrewDRW-2688-002025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCQRY2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCQRY2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCQRY2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCQRY2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCQRY2025-12-01
07640178061811pearltecPearl Technology AGIWY2025-07-28
04719879740615Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741179Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741186Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741193Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741209Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741216Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741223Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741230Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741247Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741162Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-11
04719879741285Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-10
04719879741261Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741278Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741292Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741308Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741315Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741322Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741339Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
00850043319146Head StabilizerHyperfine Operations, Inc.IWY2024-12-11
00817421022920X-GuideXNAV TECHNOLOGIES LLCQRY2024-12-09
00817421023361X-GuideXNAV TECHNOLOGIES LLCQRY2024-12-09
00817421022791X-GuideXNAV TECHNOLOGIES LLCQRY2024-10-08
00817421022784X-GuideXNAV TECHNOLOGIES LLCQRY2024-09-06
00817421022814X-GuideXNAV TECHNOLOGIES LLCQRY2024-09-06