Home GUDID 20705031245737 E-PACK
Primary DI 20705031245737
Brand E-PACK
Company Ethicon Inc.
Model 9946E
Catalog number 9946E
Device description E-Pack Procedure Kit
Published 2018-05-10
Public version status Update
Distribution status Not 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 FTL Mesh, surgical, polymeric FZP CLIP, IMPLANTABLE GAM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAN SUTURE, ABSORBABLE, SYNTHETIC GAQ Suture, nonabsorbable, steel, monofilament and multifilament, sterile GAW SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE LDF ELECTRODE, PACEMAKER, TEMPORARY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTL Mesh, Surgical, Polymeric General, Plastic Surgery 2 FZP Clip, Implantable General, Plastic Surgery 2 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery 2 GAN Suture, Absorbable, Synthetic General, Plastic Surgery 2 GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery 2 GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery 2 LDF Electrode, Pacemaker, Temporary Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30705031245734 Package GS1 5 Not in Commercial Distribution 20705031245737 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30705031245734 30705031245734 20705031245737 20705031245737
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Away from moisture and direct heat Storage Environment Temperature 0 25 Degrees Celsius
Regulatory Flags# DUNS number 002144145 Device count 1 Premarket exempt true 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 00848782052493 Sharpoint Surgical Specialties México, S. de R.L. de C.V. GAM 2026-07-06 00848782052509 Sharpoint Surgical Specialties México, S. de R.L. de C.V. GAM 2026-07-06 05060267134561 FORCECORD Implant XIROS LTD FTL 2026-07-06 17891338994365 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994389 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994396 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994440 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994457 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994501 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994532 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994556 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994563 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994570 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994839 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 17891338994860 VICRYL RAPIDE ETHICON, LLC GAM 2026-07-03 00840277412065 Vilet RIVERPOINT MEDICAL, LLC GAM 2026-06-08 04717480902064 InnoClip TAIWAN SURGICAL CORPORATION FZP 2026-06-05 04717480902101 InnoClip TAIWAN SURGICAL CORPORATION FZP 2026-06-05 04717480902149 InnoClip TAIWAN SURGICAL CORPORATION FZP 2026-06-05 04717480902170 InnoClip TAIWAN SURGICAL CORPORATION FZP 2026-06-05 04717480902217 InnoClip TAIWAN SURGICAL CORPORATION FZP 2026-06-05 04717480902293 InnoClip TAIWAN SURGICAL CORPORATION FZP 2026-06-05 07757093001539 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001553 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001560 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001621 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001638 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001652 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001683 SUTUMED Unilene S.A.C. GAN 2023-01-09 07757093001829 SUTUMED Unilene S.A.C. GAN 2023-01-09
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