GUDID EATO430490SINGLE9

Washer, I-ø8.5, O-ø13.0

aap Implantate AG

Orthopaedic bone washer, non-sterile
Primary Device IDEATO430490SINGLE9
NIH Device Record Keyc8777adb-2977-47ac-833a-dd2aebe18a39
Commercial Distribution StatusIn Commercial Distribution
Version Model Number430490SINGLE
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
HIBCCEATO430490SINGLE9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWASHER, BOLT NUT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


[EATO430490SINGLE9]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-15

Devices Manufactured by aap Implantate AG

04042409042102 - NA2025-03-06 Direct measuring device for K-Wire, L 250
04042409451348 - NA2025-03-06 K-Wire with trocar point and thread, Ø2.4, L 250
04042409452000 - NA2025-03-06 Drill, Ø2.0, cannulated, I-Ø1.1, L 130, quick coupling
04042409452024 - NA2025-03-06 Drill, Ø2.0, cannulated, I-Ø1.1, L 130, quick coupling, Single Use
04042409452062 - NA2025-03-06 Drill, Ø2.5, cannulated, I-Ø1.3, L 145, quick coupling
04042409452086 - NA2025-03-06 Drill, Ø2.5, cannulated, I-Ø1.3, L 145, quick coupling, Single Use
04042409452123 - NA2025-03-06 Drill, Ø3.7, cannulated, I-Ø1.75, L 215, quick coupling
04042409452147 - NA2025-03-06 Drill, Ø3.7, cannulated, I-Ø1.75, L 215, quick coupling, Single Use

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.