FDA.reportPublic FDA data

Tap adapter

Primary DI
E219J532200111
Brand
Tap adapter
Company
ALTATEC GmbH
Model
J5322.0011
Catalog number
J5322.0011
Device description
Tap adapter, long
Published
2018-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
E219J90220011100Direct MarkingHIBCC0
E219J532200111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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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