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 00198506044366 ELMED ELMED INCORPORATED GCJ 2026-06-09 00198506091285 ELMED INCORPORATED ELMED INCORPORATED HCF 2026-06-09 00812231033906 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231033913 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231033920 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231034095 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231034101 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 04717480900336 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900343 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900350 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900367 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900398 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900404 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900763 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900770 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900787 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900800 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 E496C05HPDH0 Handle for pneumodissection Hook AB MEDICA GCJ 2026-06-08 E496C05IDCH20ST1 Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single use AB MEDICA GCJ 2026-06-08 E496C05IDCH33ST1 Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single use AB MEDICA GCJ 2026-06-08 E496C35IDCH20ST1 Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single use AB MEDICA GCJ 2026-06-08 E496C35IDCH33ST1 Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single use AB MEDICA GCJ 2026-06-08 00198506091414 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-05 00198506091421 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-05 00198506091438 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-05 00198506091247 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-03 00198506091254 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-03 00192896123427 Trocar SONTEC INSTRUMENTS, INC. GCJ 2026-06-02 00192896123434 Flexible Trocar Sleeve SONTEC INSTRUMENTS, INC. GCJ 2026-06-02 00192896123441 Barraquer Anis Needle Holder SONTEC INSTRUMENTS, INC. HCF 2026-06-02