Cannulated Screws SU 0916-00-2

GUDID 04042409088506

Washer, I-ø8.6, O-ø16.0 Titanium

aap Implantate AG

Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer
Primary Device ID04042409088506
NIH Device Record Key8b15a53c-edc0-48c4-9ca0-3240793bed65
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Screws
Version Model NumberSU 0916-00-2
Catalog NumberSU 0916-00-2
Company DUNS328420633
Company Nameaap Implantate AG
Device Count5
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
GS104042409088506 [Primary]
GS104042409438943 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


[04042409088506]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-21
Device Publish Date2020-12-11

On-Brand Devices [Cannulated Screws]

04042409088506Washer, I-ø8.6, O-ø16.0 Titanium
04042409088483Washer, I-ø8.5, O-ø13.0 Titanium
04042409088452Washer, I-ø6.6, O-ø13.0 Titanium
04042409088438Washer, I-ø4.5, O-ø8.0 Titanium
04042409088407Washer, I-ø4.0, O-ø8.0 Titanium
04042409088384Washer, I-ø2.2, O-ø4.5 Titanium
04042409185649Cannulated Screw 3.5, L 55, full thread Titanium
04042409077999Cannulated Screw 7.5, L 125, full thread Titanium

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.