Home GUDID 00810072350909 Self-Filling Device
Primary DI 00810072350909
Brand Self-Filling Device
Company Cole Instruments Inc
Model Self-Filling Device
Catalog number 500.002
Device description Self-Filling Device
Published 2021-02-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810072350909 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 00810072350909 00810072350909 810072350909 0810072350909
GMDN Terms# Term, Definition table Term Definition Syringe-loaded injector, manual, professional A hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) or subcutaneously. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 078573265 Device count 1 Premarket exempt true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810072350503 0.80 mm window punch, 5 pack IHTI-0.80-2S-094-WP punch 109.080 2021-02-04 00810072350510 0.80 mm window punch, 10 pack IHTI-0.80-2S-094-WP punch 109.080 2021-02-04 00810072351197 Graft Slivering Board Graft Slivering Board 621.000 2022-12-08 00810072351005 mini Powered Cole Isolation Device mPCID 910.000 2021-02-04 00810072351159 Graft Storage Plate Graft Storage Plate 360.100 2022-12-08 00810072350046 0.80 mm regular punch, 5 pack CI-0.80-3C-094 punch 102.080 2021-02-04 00810072350053 0.80 mm regular punch, 10 pack CI-0.80-3C-094 punch 102.080 2021-02-04 00810072350060 0.85 mm regular punch, 5 pack CI-0.85-3C-094 punch 102.085 2021-02-04 00810072350077 0.85 mm regular punch, 10 pack CI-0.85-3C-094 punch 102.085 2021-02-04 00810072350084 0.90 mm regular punch, 5 pack CI-0.90-3C-094 punch 102.090 2021-02-04 00810072350091 0.90 mm regular punch, 10 pack CI-0.90-3C-094 punch 102.090 2021-02-04 00810072350107 0.95 mm regular punch, 5 pack CI-0.95-3C-094 punch 102.095 2021-02-04 00810072350114 0.95 mm regular punch, 10 pack CI-0.95-3C-094 punch 102.095 2021-02-04 00810072350121 1.00 mm regular punch, 5 pack CI-1.00-3C-094 punch 102.100 2021-02-04 00810072350138 1.00 mm regular punch, 10 pack CI-1.00-3C-094 punch 102.100 2021-02-04 00810072350145 1.05 mm regular punch, 5 pack CI-1.05-3C-094 punch 102.105 2021-02-04 00810072350152 1.05 mm regular punch, 10 pack CI-1.05-3C-094 punch 102.105 2021-02-04 00810072350169 1.10 mm regular punch, 5 pack CI-1.10-3C-094 punch 102.110 2021-02-04 00810072350176 1.10 mm regular punch, 10 pack CI-1.10-3C-094 punch 102.110 2021-02-04 00810072350220 0.90 mm non-coated titanium punch, 5 pack CI-0.90-2T1-094 punch 103.090 2021-02-04
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