Home GUDID 04048223057650 MonoBalloon DIL-XL
Primary DI 04048223057650
Brand MonoBalloon DIL-XL
Company Pajunk GmbH Medizintechnologie
Model 1284-60-11
Catalog number 1284-60-11
Device description MonoBalloon DIL-XL Unilateral dilatation balloon Ø11mm round, Extra Large
Published 2025-03-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GCJ Laparoscope, general & plastic surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04048223057650 Package GS1 5 In Commercial Distribution 04048223078235 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04048223057650 04048223057650 4048223057650 04048223078235 04048223078235 4048223078235
GMDN Terms# Term, Definition table Term Definition Surgical balloon dissector A device used to dissect connective tissue layers creating access to a surgical site for a variety of surgical procedures. The device typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. The balloon is inflated to fill volume exerting pressure on the tissue layers. It is then deflated and removed, and distention is maintained by infusion of carbon dioxide (CO2) via the cannula. This device can be used for hernia repair, varicocele dissection, sympathectomy, lymph node biopsy, or perforator vein ligation. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Lumen/Inner Diameter 11 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 20 Percent (%) Relative Humidity 65 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 317654283 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776421731 Millennium Avalign Technologies, Inc. GCJ 2026-06-24 00190776421663 Millennium Avalign Technologies, Inc. GCJ 2026-06-23 00190776421687 Millennium Avalign Technologies, Inc. GCJ 2026-06-23 00198506091506 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-10 00198506044366 ELMED ELMED INCORPORATED GCJ 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
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