FDA.reportPublic FDA data

Orthonia/Accessary

Primary DI
08809265157991
Brand
Orthonia/Accessary
Company
Jeil Medical Corporation
Model
111-ED-010
Published
2018-09-07
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
MOQBattery, Replacement, Rechargeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOQBattery, Replacement, RechargeableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809265157991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809265157991088092651579918809265157991

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811603
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089479450ARIX System Bone Screw35N-SO-L20-TA2026-06-01
08800089479467ARIX System Bone Screw35N-SO-L22-TA2026-06-01
08800089479474ARIX System Bone Screw35N-SO-L24-TA2026-06-01
08800089479481ARIX System Bone Screw35N-SO-L26-TA2026-06-01
08800089479498ARIX System Bone Screw35N-SO-L28-TA2026-06-01
08800089479504ARIX System Bone Screw35N-SO-L30-TA2026-06-01
08800089479511ARIX System Bone Screw35N-SO-L32-TA2026-06-01
08800089479528ARIX System Bone Screw35N-SO-L34-TA2026-06-01
08800089479535ARIX System Bone Screw35N-SO-L36-TA2026-06-01
08800089479542ARIX System Bone Screw35N-SO-L38-TA2026-06-01
08800089479559ARIX System Bone Screw35N-SO-L40-TA2026-06-01
08800089479566ARIX System Bone Screw35N-SO-L42-TA2026-06-01
08800089479573ARIX System Bone Screw35N-SO-L44-TA2026-06-01
08800089479580ARIX System Bone Screw35N-SO-L46-TA2026-06-01
08800089479597ARIX System Bone Screw35N-SO-L48-TA2026-06-01
08800089479603ARIX System Bone Screw35N-SO-L50-TA2026-06-01
08800089479610ARIX System Bone Screw35N-SO-L52-TA2026-06-01
08800089479627ARIX System Bone Screw35N-SO-L56-TA2026-06-01
08800089479634ARIX System Bone Screw35N-SO-L60-TA2026-06-01
08800089479641ARIX System Bone Screw40N-SA-020-T2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934726614453Battery PackLongfian Scitech Co., Ltd.MOQ2026-04-25
30845854052079HALLConmed CorporationMOQ2026-04-01
00819595011175Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015029Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015661Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015685Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015692Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015876Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015906Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015944Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016040Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016118Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016125Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016149Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016163Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016750Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016781Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016828Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016880Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016897Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016910Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016934Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016941Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016958Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016965Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016972Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017092Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017108Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017115Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017122Artisan PowerArtisan Power LLCMOQ2026-02-10