Distraction Pin, 14MM pouch

GUDID 10818614022618

Sharp Distraction Pin, 14MM pouch

Maruho Medical, Inc.

Intraoperative orthopaedic bone pin/screw, single-use
Primary Device ID10818614022618
NIH Device Record Keyf3c26bbc-41be-40ee-a3a0-7723ce731413
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistraction Pin, 14MM pouch
Version Model NumberSS-0089S
Company DUNS117630237
Company NameMaruho Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100818614022611 [Primary]
GS110818614022618 [Package]
Contains: 00818614022611
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

LYQAccessories, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-02
Device Publish Date2022-12-19

Devices Manufactured by Maruho Medical, Inc.

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10818614022595 - Disposable Punch, 6.5 mm 2024-06-05 Disposable Punch, 6.5 mm Pouch
00818614022635 - ABS Med Distraction Pin2023-09-06 ABS Med Distraction Pin , 12MM Pouch
10818614022649 - ABS Med Distraction Pin2023-09-06 ABS Med Distraction Pin, 14MM Patient (Inner)
10818614021406 - Distraction Screw2023-06-02 Distraction Screw, 12MM Patient (Inner)
10818614021413 - Distraction Screw2023-06-02 Distraction Screw, 14MM Patient (Inner)
10818614022601 - Distraction Pin, 12MM pouch2023-06-02 Sharp Distraction Pin, 12MM pouch
10818614022618 - Distraction Pin, 14MM pouch2023-06-02Sharp Distraction Pin, 14MM pouch
10818614022618 - Distraction Pin, 14MM pouch2023-06-02 Sharp Distraction Pin, 14MM pouch

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