Trephine

GUDID 00846338002343

ELLIQUENCE, LLC

Spinal endoscopic-access system
Primary Device ID00846338002343
NIH Device Record Keyc2e8d9a7-4dff-43f1-bffe-421561d9e2a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine
Version Model Number11-2613
Company DUNS019872358
Company NameELLIQUENCE, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100846338002343 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


[00846338002343]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-15
Device Publish Date2025-01-07

On-Brand Devices [Trephine]

0084633800235011-2614
0084633800234311-2613
0084633800233611-2612
0084633800232911-2611
0084633800526911-2617

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