GUDID 04042409240713

Parallel guide for K-wires, CS 6.5/7.5

aap Implantate AG

Orthopaedic implant aiming/guiding block attachment tool
Primary Device ID04042409240713
NIH Device Record Key92e8bab8-c480-40c4-8466-3c7757a3beb6
Commercial Distribution Discontinuation2025-01-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number430440
Company DUNS328420633
Company Nameaap Implantate AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104042409240713 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


[04042409240713]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-01-16
Device Publish Date2018-02-28

Devices Manufactured by aap Implantate AG

04042409240447 - NA2025-01-16 Drill CS 4.0, ø2.5, L 130, quick coupling, single use
04042409240454 - NA2025-01-16 Drill CS 4.5, ø3.0, L 130, quick coupling, single use
04042409240461 - NA2025-01-16 Drill CS 4.0, ø4.0, L 130, quick coupling, single use
04042409240478 - NA2025-01-16 Drill CS 4.5, ø4.5, L 130, quick coupling, single use
04042409240485 - NA2025-01-16 Cannulated drill CS 6.5, ø4.4, L 220, Hudson, single use
04042409240508 - NA2025-01-16 Countersink CS 6.5/7.5, Hudson
04042409240713 - NA2025-01-16Parallel guide for K-wires, CS 6.5/7.5
04042409240713 - NA2025-01-16 Parallel guide for K-wires, CS 6.5/7.5
04042409240744 - NA2025-01-16 Screwdriver cannulated CS 6.5/7.5, hex, ø5.0, Hudson

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