FDA.reportPublic FDA data

Cleaning needle

Primary DI
E219J500200121
Brand
Cleaning needle
Company
ALTATEC GmbH
Model
J5002.0012
Catalog number
J5002.0012
Device description
Cleaning needle for drills with internal irrigation
Published
2023-09-06
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
E219J500200121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E219J590020001Universal cone disconnectorJ5900.2000J5900.20002026-02-10
E219K590133001CAMLOG® Connection Reamer SetK5901.3300K5901.33002026-02-10
E219K590138001CAMLOG® Connection Reamer SetK5901.3800K5901.38002026-02-10
E219K590143001CAMLOG® Connection Reamer SetK5901.4300K5901.43002026-02-10
E219K590150001CAMLOG® Connection Reamer SetK5901.5000K5901.50002026-02-10
E219J508133091Guide dense bone drill 2, PLJ5081.3309J5081.33092025-05-13
E219J508133111Guide dense bone drill 2, PLJ5081.3311J5081.33112025-05-13
E219J508133131Guide dense bone drill 2, PLJ5081.3313J5081.33132025-05-13
E219J508133161Guide dense bone drill 2, PLJ5081.3316J5081.33162025-05-13
E219J508138071Guide dense bone drill 2, PLJ5081.3807J5081.38072025-05-13
E219J508138091Guide dense bone drill 2, PLJ5081.3809J5081.38092025-05-13
E219J508138111Guide dense bone drill 2, PLJ5081.3811J5081.38112025-05-13
E219J508138131Guide dense bone drill 2, PLJ5081.3813J5081.38132025-05-13
E219J508138161Guide dense bone drill 2, PLJ5081.3816J5081.38162025-05-13
E219J508143071Guide dense bone drill 2, PLJ5081.4307J5081.43072025-05-13
E219J508143091Guide dense bone drill 2, PLJ5081.4309J5081.43092025-05-13
E219J508143111Guide dense bone drill 2, PLJ5081.4311J5081.43112025-05-13
E219J508143131Guide dense bone drill 2, PLJ5081.4313J5081.43132025-05-13
E219J508143161Guide dense bone drill 2, PLJ5081.4316J5081.43162025-05-13
E219J508150071Guide dense bone drill 2, PLJ5081.5007J5081.50072025-05-13

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