Home GUDID 20650862301018 PROLITE
Primary DI 20650862301018
Brand PROLITE
Company ATRIUM MEDICAL CORPORATION
Model 1010101-01
Device description ProLite Mesh S, 1.0in. x 2in. (2.5cm x 5cm), 4in. (10cm)
Published 2015-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FTL Mesh, surgical, polymeric
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTL Mesh, Surgical, Polymeric General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20650862301018 Package GS1 5 In Commercial Distribution 00650862301014 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20650862301018 20650862301018 00650862301014 00650862301014 650862301014 0650862301014
GMDN Terms# Term, Definition table Term Definition Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable A sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of one or more non-bioabsorbable synthetic polymers [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
Regulatory Flags# DUNS number 051798999 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 false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00650862122916 iCast covered stent system, 12mm x 29mm x 80cm GBX12291A 2026-02-18 00650862122923 iCast covered stent system, 12mm x 29mm x 120cm GBX12292A 2026-02-18 00650862124118 iCast covered stent system, 12mm x 41mm x 80cm GBX12411A 2026-02-18 00650862124125 iCast covered stent system, 12mm x 41mm x 120cm GBX12412A 2026-02-18 00650862126112 iCast covered stent system, 12mm x 61mm x 80cm GBX12611A 2026-02-18 00650862126129 iCast covered stent system, 12mm x 61mm x 120cm GBX12612A 2026-02-18 00650862425321 iCast covered stent system, 5mm x 32mm x 120cm 42532 2026-02-18 00650862426328 iCast covered stent system, 6mm x 32mm x 120cm 42632 2026-02-18 00650862427325 iCast covered stent system, 7mm x 32mm x 120cm 42732 2026-02-18 00650862428322 iCast covered stent system, 8mm x 32mm x 120cm 42832 2026-02-18 00650862429329 iCast covered stent system, 9mm x 32mm x 120cm 42932 2026-02-18 00650862480597 iCast covered stent system, 10mm x 59mm x 80cm 48059 2026-02-18 00650862485325 iCast covered stent system, 5mm x 32mm x 80cm 48532 2026-02-18 00650862486322 iCast covered stent system, 6mm x 32mm x 80cm 48632 2026-02-18 00650862487329 iCast covered stent system, 7mm x 32mm x 80cm 48732 2026-02-18 00650862488326 iCast covered stent system, 8mm x 32mm x 80cm 48832 2026-02-18 00650862489323 iCast covered stent system, 9mm x 32mm x 80cm 48932 2026-02-18 00650862720594 iCast covered stent system, 10mm x 59mm x 120cm 72059 2026-02-18 00650862420388 iCast Covered Stent System, 10mmX38mmX120cm 42038 42038 2023-06-09 00650862425161 iCast Covered Stent System, 5mmX16mmX120cm 42516 42516 2023-06-09
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