NK 1012-20-2

GUDID 04042409048692

K-wire with thread and trocar point, ø1.2, L 200

aap Implantate AG

Orthopaedic bone wire Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID04042409048692
NIH Device Record Key9d869483-a896-4918-b93f-670595d338ad
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNK 1012-20-2
Catalog NumberNK 1012-20-2
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
GS104042409048692 [Primary]
GS104042409391194 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

Moist Heat or Steam Sterilization


[04042409048692]

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

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04042409038013 - NA2024-07-15 Cleaning wire ø3.0, CS 7.5
04042409097263 - NA2024-07-15 Cleaning wire ø2.0, CS 5.8
04042409097324 - NA2024-07-15 Cleaning wire ø2.5, CS 6.5
04042409196409 - NA2024-07-15 Cleaning wire ø0.8, CS 2.0/2.7
04042409197338 - NA2024-07-15 Drill CS 4.0, ø2.5, L 130, I-ø1.4, single use
04042409197369 - NA2024-07-15 Drill CS 3.5, ø2.7, L 120, I-ø1.4, single use

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