Home GUDID 04719872920328 AbClose
Primary DI 04719872920328
Brand AbClose
Company MEDEON BIODESIGN, INC.
Model M12 Rev.V24
Catalog number M12
Device description The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision.
Published 2021-04-27
Public version status New
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 GCJ Laparoscope, General & Plastic Surgery HCF Instrument, Ligature Passing And Knot Tying OCW Endoscopic Tissue Approximation Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2 HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery 1 OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719872920335 Package GS1 5 In Commercial Distribution 04719872920342 Package GS1 2 In Commercial Distribution 04719872920328 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719872920335 04719872920335 4719872920335 04719872920342 04719872920342 4719872920342 04719872920328 04719872920328 4719872920328
GMDN Terms# Term, Definition table Term Definition Gastrointestinal endoscopic clip, long-term, non-bioabsorbable A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Dry
Regulatory Flags# DUNS number 656078460 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776427931 Millennium Avalign Technologies, Inc. GCJ 2026-08-27 00190776428051 Millennium Avalign Technologies, Inc. GCJ 2026-08-27 00190776428303 Millennium Avalign Technologies, Inc. GCJ 2026-08-27 00190776427429 Millennium Avalign Technologies, Inc. GCJ 2026-08-26 04580826928451 PENTAX Medical PENTAX MEDICAL CORPORATION GCJ 2026-08-25 04580826928543 PENTAX Medical PENTAX MEDICAL CORPORATION GCJ 2026-08-25 04580826928581 PENTAX Medical PENTAX MEDICAL CORPORATION GCJ 2026-08-25 04580826928604 PENTAX Medical PENTAX MEDICAL CORPORATION GCJ 2026-08-25 08800035701499 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701505 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701512 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701529 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701536 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701543 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701949 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701956 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 08800035701963 CORE-Trocar INCORE CO., LTD GCJ 2026-08-25 B382SD13448970 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 B382SD16008970 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 B382SD161730 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 B382SD77205052000 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 B382SD77205082000 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 B382SD7720508TS2000 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 B382SD77205252000 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-21 00190776425883 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776425906 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776425968 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776425975 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776426361 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776426378 Millennium Avalign Technologies, Inc. GCJ 2026-08-18