GUDID EATO430125SINGLE9

K-wire with trocar point, ø1.2, L 150

aap Implantate AG

Orthopaedic bone wire
Primary Device IDEATO430125SINGLE9
NIH Device Record Keyacee6ec6-bddc-4a75-a8f9-ce486e77f9ef
Commercial Distribution StatusIn Commercial Distribution
Version Model Number430125SINGLE
Company DUNS328420633
Company Nameaap Implantate AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
HIBCCEATO430125SINGLE9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


[EATO430125SINGLE9]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-16
Device Publish Date2016-10-13

Devices Manufactured by aap Implantate AG

04042409042256 - NA2025-04-09 Screw forceps, long
04042409042270 - NA2025-04-09 Screw forceps, self-holding
04042409194610 - NA2025-04-09 Aiming device Radius 2.5, broad, R
04042409194627 - NA2025-04-09 Aiming device Radius 2.5, broad, L
04042409194641 - NA2025-04-09 Aiming device Radius 2.5, narrow, R
04042409194665 - NA2025-04-09 Aiming device Radius 2.5, narrow, L
04042409194672 - NA2025-04-09 Aiming device Radius 2.5, R
04042409194689 - NA2025-04-09 Aiming device Radius 2.5, L

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