Flexible Osteotome System with Radel Case 2709-04-000; 30-005-000-1500

GUDID 00847538015256

Flexible Osteotome System with Radel Case

SYMMETRY MEDICAL INC.

Device sterilization/disinfection container, reusable
Primary Device ID00847538015256
NIH Device Record Key5ea7b364-962d-4de9-a38d-3d2c8dbb3cc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Osteotome System with Radel Case
Version Model Number30-005-000
Catalog Number2709-04-000; 30-005-000-1500
Company DUNS079881212
Company NameSYMMETRY MEDICAL 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 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
GS100847538015256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


[00847538015256]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-25
Device Publish Date2023-07-17

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00847538009293 - Short Radial Osteotome Blade2023-10-02 Short Radial Osteotome Blade
00847538009316 - Medium Radial Osteotome Blade2023-10-02 Medium Radial Osteotome Blade
00847538009354 - Long Flat Osteotome Blade2023-10-02 Long Flat Osteotome Blade
00847538009378 - Medium Flat Osteotome Blade2023-10-02 Medium Flat Osteotome Blade
00847538018721 - GLOBAL UNITE™ Short Stem Instrumentation2023-09-13 SHORT BULLET TIP REAMER 8MM

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