NK 0014-15-2

GUDID 04042409047879

K-wire with trocar point, ø1.4, L 150

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 ID04042409047879
NIH Device Record Key7b3344bf-5622-4065-8283-5acc25aa5c8e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNK 0014-15-2
Catalog NumberNK 0014-15-2
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
GS104042409047879 [Primary]
GS104042409390715 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

Moist Heat or Steam Sterilization


[04042409047879]

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

04042409037993 - NA2024-07-15 Cleaning wire ø1.2, CS 2.7-4.0
04042409038006 - NA2024-07-15 Cleaning wire ø1.6, CS 4.5
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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