NK 1016-20-2

GUDID 04042409048869

K-wire with thread and trocar point, ø1.6, L 200

aap Implantate AG

Orthopaedic bone wire
Primary Device ID04042409048869
NIH Device Record Keycddbefa9-ebf1-42b0-892d-2cce312cb5fa
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNK 1016-20-2
Catalog NumberNK 1016-20-2
Company DUNS328420633
Company Nameaap Implantate AG
Device Count10
DM Exempttrue
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
GS104042409048869 [Primary]
GS104042409391255 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409048869]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-08-18

Devices Manufactured by aap Implantate AG

04042409047657 - NA2024-02-19 K-wire with trocar point, ø0.8, L 150
04042409047695 - NA2024-02-19 K-wire with trocar point, ø0.8, L 310
04042409047701 - NA2024-02-19 K-wire with trocar point, ø1.0, L 100
04042409047718 - NA2024-02-19 K-wire with trocar point, ø1.0, L 150
04042409047725 - NA2024-02-19 K-wire with trocar point, ø1.0, L 150
04042409047732 - NA2024-02-19 K-wire with trocar point, ø1.0, L 200
04042409047749 - NA2024-02-19 K-wire with trocar point, ø1.0, L 250
04042409047763 - NA2024-02-19 K-wire with trocar point, ø1.0, L 310

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