FDA.reportPublic FDA data

Holding sleeve for screw implants

Primary DI
E219J530243001
Brand
Holding sleeve for screw implants
Company
ALTATEC GmbH
Model
J5302.4300
Catalog number
J5302.4300
Device description
Holding sleeve for screw implants, Ø 4.3 mm
Published
2018-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E219J530243001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999info@camlog.com

Regulatory Flags#

DUNS number
322018193
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
04099797000726Drill for CT-tubeA2050.2600A2050.26002026-08-17
04099797000733Drill for CT-tubeA2050.2800A2050.28002026-08-17
04099797009200CONELOG® / iSy® Bonding aidC4019.1600C4019.16002026-08-17
04099797009217CONELOG® / iSy® Bonding aidC4019.2000C4019.20002026-08-17
04099797000337CONELOG® SCREW-LINE ImplantC1065.3309C1065.33092026-08-17
04099797000344CONELOG® SCREW-LINE ImplantC1065.3311C1065.33112026-08-17
04099797000351CONELOG® SCREW-LINE ImplantC1065.3313C1065.33132026-08-17
04099797000368CONELOG® SCREW-LINE ImplantC1065.3316C1065.33162026-08-17
04099797000375CONELOG® SCREW-LINE ImplantC1065.3807C1065.38072026-08-17
04099797000382CONELOG® SCREW-LINE ImplantC1065.3809C1065.38092026-08-17
04099797000399CONELOG® SCREW-LINE ImplantC1065.3811C1065.38112026-08-17
04099797000405CONELOG® SCREW-LINE ImplantC1065.3813C1065.38132026-08-17
04099797000412CONELOG® SCREW-LINE ImplantC1065.3816C1065.38162026-08-17
04099797000429CONELOG® SCREW-LINE ImplantC1065.4307C1065.43072026-08-17
04099797000436CONELOG® SCREW-LINE ImplantC1065.4309C1065.43092026-08-17
04099797000443CONELOG® SCREW-LINE ImplantC1065.4311C1065.43112026-08-17
04099797000450CONELOG® SCREW-LINE ImplantC1065.4313C1065.43132026-08-17
04099797000467CONELOG® SCREW-LINE ImplantC1065.4316C1065.43162026-08-17
04099797000474CONELOG® SCREW-LINE ImplantC1065.5007C1065.50072026-08-17
04099797000481CONELOG® SCREW-LINE ImplantC1065.5009C1065.50092026-08-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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