Home GUDID 04714127867953 OmniClose trocar site closure device
Primary DI 04714127867953
Brand OmniClose trocar site closure device
Company UNIMAX MEDICAL SYSTEMS INC.
Model FCL215000
Published 2018-04-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GDF Guide, Needle, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDF Guide, Needle, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14714127867950 Package GS1 10 In Commercial Distribution 24714127867957 Package GS1 10 In Commercial Distribution 04714127867953 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14714127867950 14714127867950 24714127867957 24714127867957 04714127867953 04714127867953 4714127867953
GMDN Terms# Term, Definition table Term Definition Suturing unit, single-use A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
Regulatory Flags# DUNS number 658122465 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10197344044795 MEDLINE MEDLINE INDUSTRIES, INC. GDF 2025-09-23 10197344044801 MEDLINE MEDLINE INDUSTRIES, INC. GDF 2025-09-23 ESAM14762481 STOMA® Storz am Mark GmbH GDF 2025-04-30 07630037864523 APTUS Medartis AG GDF 2025-04-08 07630037864547 APTUS Medartis AG GDF 2025-04-08 07630037864561 APTUS Medartis AG GDF 2025-04-08 07630037864585 APTUS Medartis AG GDF 2025-04-08 10197106342312 CARDINAL HEALTH Cardinal Health 200, LLC GDF 2024-04-01 07630037864165 APTUS Medartis AG GDF 2024-03-22 ESAM14755481 STOMA® Storz am Mark GmbH GDF 2023-11-20 ESAM14760481 STOMA® Storz am Mark GmbH GDF 2023-06-05 ESAM14761481 STOMA® Storz am Mark GmbH GDF 2023-06-05 ESAM14750481 STOMA® Storz am Mark GmbH GDF 2022-11-07 ESAM14751481 STOMA® Storz am Mark GmbH GDF 2022-11-07 08033860028596 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 08033860028602 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 08033860030353 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 10840199534132 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534149 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534156 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534163 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534170 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534187 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534194 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534200 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534217 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534224 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534231 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534248 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534255 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01