SC 4500-48-2

GUDID 04042409075520

Cannulated screw 4.5, full thread, L 48

aap Implantate AG

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID04042409075520
NIH Device Record Key2bc8b036-34d1-470f-a3ce-b224f586bc11
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSC 4500-48-2
Catalog NumberSC 4500-48-2
Company DUNS328420633
Company Nameaap Implantate AG
Device Count1
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
GS104042409075520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409075520]

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

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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

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