Home GUDID 00810102271235 Dermapac, Inc.
Primary DI 00810102271235
Brand Dermapac, Inc.
Company Dermapac Inc.
Model 8323
Device description Cut Down Set
Published 2022-09-12
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 FSM Tray, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10810102271232 Primary GS1 0 00810102271235 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10810102271232 10810102271232 00810102271235 00810102271235 810102271235 0810102271235
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.
Regulatory Flags# DUNS number 796088466 Device count 5 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false 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 10810102271560 Dermapac, Inc. 9960 2022-07-12 10810102270112 Dermapac, Inc. 2036 2022-09-12 10810102270150 Dermapac, Inc. 2087 2022-09-12 10810102270235 Dermapac, Inc. 5008 2022-09-12 10810102270242 Dermapac, Inc. 5008-A 2022-09-12 10810102271546 Dermapac, Inc. 9910 2022-09-12 10810102271553 Dermapac, Inc. 9911 2022-09-12 10810102271683 Dermapac, Inc. 9979 2022-09-12 10810102270006 Dermapac, Inc. 1803 2022-09-12 10810102270013 Dermapac, Inc. 1804 2022-09-12 10810102270020 Dermapac, Inc. 1805 2022-09-12 10810102270037 Dermapac, Inc. 1809 2022-09-12 10810102270044 Dermapac, Inc. 1810 2022-09-12 10810102270051 Dermapac, Inc. 1812 2022-09-12 10810102270068 Dermapac, Inc. 1814 2022-09-12 10810102270075 Dermapac, Inc. 1815 2022-09-12 10810102270082 Dermapac, Inc. 1832 2022-09-12 10810102270099 Dermapac, Inc. 1860 2022-09-12 10810102270105 Dermapac, Inc. 2034 2022-09-12 10810102270129 Dermapac, Inc. 2038 2022-09-12
Other Devices Sharing Product Codes#