Champion Suture Passer Ratchet Straight Capture

GUDID 00860794002624

Champion Suture Passer Ratchet Straight Capture

Lincotek Medical LLC

Suturing needle holder, reusable
Primary Device ID00860794002624
NIH Device Record Key1a25f1a4-6d5a-4564-bccd-90b9984f9592
Commercial Distribution StatusIn Commercial Distribution
Brand NameChampion Suture Passer Ratchet Straight Capture
Version Model Number3910-900-088
Company DUNS117021487
Company NameLincotek Medical 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860794002624 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


[00860794002624]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-10
Device Publish Date2024-01-02

Devices Manufactured by Lincotek Medical LLC

00860794002679 - Versipass Suture Passer Needle2024-10-25 Suture passer needle for the Versipass Suture Passer
00860794002600 - Champion Suture Passer Ratchet Straight2024-01-10 Champion Suture Passer Ratchet Straight
00860794002617 - Champion Suture Passer Ratchet Humpback2024-01-10 Champion Suture Passer Ratchet Humpback
00860794002624 - Champion Suture Passer Ratchet Straight Capture2024-01-10Champion Suture Passer Ratchet Straight Capture
00860794002624 - Champion Suture Passer Ratchet Straight Capture2024-01-10 Champion Suture Passer Ratchet Straight Capture
00860794002631 - Champion Suture Passer Ratchet Humpback Capture2024-01-10 Champion Suture Passer Ratchet Humpback Capture
00860794002655 - Champion Suture Passer Needle2023-12-26 Champion Passer Needle - single needle
00860794002662 - Versipass Suture Passer2023-12-20 The VersiPass Suture Passer instrument is a reusable manual surgical instrument used to pass sutures for arthroscopic and open r

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