N/A

GUDID 00818614021874

Reusable Surgical Bone Tunnel Reamer, 6.0mm

Maruho Medical, Inc.

Bone-resection orthopaedic reamer, reusable

Primary Device ID	00818614021874
NIH Device Record Key	068a9d26-b302-4ed5-b2cd-2faa01b37262
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	0304-060
Company DUNS	117630237
Company Name	Maruho Medical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
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	00818614021874 [Primary]

FDA Product Code

Reamer

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

[00818614021874]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-25
Device Publish Date	2021-03-17

On-Brand Devices [N/A]

00818614022321	Reusable Obturator, 8.5mm x 90mm
00818614022314	Reusable Obturator, 8.5mm x 70mm
00818614022307	Reusable Obturator, 7.5mm x 90mm
00818614022291	Reusable Obturator, 7.5mm x 70mm
00818614022284	Reusable Obturator, 6.5mm x 90mm
00818614022277	Reusable Obturator, 6.5mm x 70mm
00818614022260	Switching Stick, 4.0mm x 305mm
00818614022253	Reusable Obturator, 8.5mm x 90mm
00818614022246	Reusable Obturator, 8.5mm x 70mm
00818614022239	Reusable Obturator, 7.5mm x 90mm
00818614022222	Reusable Obturator, 7.5mm x 70mm
00818614022215	Reusable Obturator, 6.5mm x 90mm
00818614022208	Reusable Obturator, 6.5mm x 70mm
00818614022192	Switching Stick, 2.6mm x 305mm
00818614022161	Small Angled Drill Guide
00818614021904	Tendon Sizer
00818614021874	Reusable Surgical Bone Tunnel Reamer, 6.0mm

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