CleverLock

GUDID 00821925043343

Guidewire Locing Device and Biopsy Cap CleverLock (10/Pk)

Gyrus Acmi, Inc.

Endoscopic guidewire holder
Primary Device ID00821925043343
NIH Device Record Key044efe68-8ab9-486a-8627-320f4ebc486f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCleverLock
Version Model NumberMAJ-2455
Company DUNS007198742
Company NameGyrus Acmi, 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 Usetrue
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
GS100821925043336 [Package]
Package: [10 Units]
In Commercial Distribution
GS100821925043343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODCEndoscope Channel Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-01
Device Publish Date2024-07-24

Devices Manufactured by Gyrus Acmi, Inc.

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00821925002074 - USA Elite System2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002098 - USA Elite System2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002111 - USA Elite System2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold

Trademark Results [CleverLock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEVERLOCK
CLEVERLOCK
88505948 not registered Live/Pending
Olympus Corporation
2019-07-09

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