Kinos Aeros Instrumentation

GUDID 00840097516349

Retrieval Instrument

Restor3d, Inc.

Joint prosthesis implantation kit, reusable
Primary Device ID00840097516349
NIH Device Record Key9a2b6168-13f6-49c7-861b-dd72b239713a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinos Aeros Instrumentation
Version Model Number5871-9015
Company DUNS080819836
Company NameRestor3d, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097516349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


[00840097516349]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-09
Device Publish Date2025-05-01

On-Brand Devices [Kinos Aeros Instrumentation ]

00840097516349Retrieval Instrument
0084009751633214mm Pilot Drill Bit

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.