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 ID	00847538015256
NIH Device Record Key	5ea7b364-962d-4de9-a38d-3d2c8dbb3cc3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flexible Osteotome System with Radel Case
Version Model Number	30-005-000
Catalog Number	2709-04-000; 30-005-000-1500
Company DUNS	079881212
Company Name	SYMMETRY MEDICAL INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847538015256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K012105

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[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 Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-07-25
Device Publish Date	2023-07-17

Devices Manufactured by SYMMETRY MEDICAL INC.

00847538009415 - Short Fin Osteotome Blade	2024-07-08 Short Fin Osteotome Blade
00847538008654 - HP Extraction Standard Removal Case	2023-12-06 HP Extraction Standard Removal Case
00847538009330 - Long Radial Osteotome Blade	2023-10-31 Long Radial Osteotome Blade
00847538009293 - Short Radial Osteotome Blade	2023-10-02 Short Radial Osteotome Blade
00847538009316 - Medium Radial Osteotome Blade	2023-10-02 Medium Radial Osteotome Blade
00847538009354 - Long Flat Osteotome Blade	2023-10-02 Long Flat Osteotome Blade
00847538009378 - Medium Flat Osteotome Blade	2023-10-02 Medium Flat Osteotome Blade
00847538018721 - GLOBAL UNITE™ Short Stem Instrumentation	2023-09-13 SHORT BULLET TIP REAMER 8MM

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