Home GUDID B686100SB01SRS0300000 NovoSort
Primary DI B686100SB01SRS0300000
Brand NovoSort
Company RSI Technology Group, LLC
Model 1
Catalog number 80001
Device description A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. The Novo is a component designed to facilitate isolation of sperm while in the ProteX.
Published 2023-08-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name PUD Labware, Assisted Reproduction, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PUD Labware, Assisted Reproduction, Exempt Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B686100SB01SRS0300000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Semen specimen collection container A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.
Regulatory Flags# DUNS number 118022050 Device count 1 Premarket exempt true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10850068289445 SFG 35mm culture dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289452 SFG 60mm culture dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289469 SFG 100mm culture dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289476 SFG ICSI dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289483 SFG Center well dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289490 SFG 4 well dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289506 SFG Sperm CD SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289513 SFG Sperm CD SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289520 SFG Sperm CD SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 10850068289537 SFG Sperm Collection Container SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289448 SFG 35mm culture dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289455 SFG 60mm culture dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289462 SFG 100mm culture dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289479 SFG ICSI dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289486 SFG Center well dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289493 SFG 4 well dish SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289509 SFG Sperm CD SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289516 SFG Sperm CD SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289523 SFG Sperm CD SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 00850068289530 SFG Sperm Collection Container SPECTRUM FERTILITY GROUP INC. PUD 2024-11-12 14580647510054 ASTEC IVF 4Well Dish ASTEC CO.,LTD. PUD 2024-08-01 14580647510061 ASTEC IVF 4Well Dish ASTEC CO.,LTD. PUD 2024-08-01 14580647510078 ASTEC IVF Center Well Dish ASTEC CO.,LTD. PUD 2024-08-01 14580647510085 ASTEC IVF ICSI Dish ASTEC CO.,LTD. PUD 2024-08-01 14580647510092 ASTEC IVF 35mm Culture Dish ASTEC CO.,LTD. PUD 2024-08-01 14580647510108 ASTEC IVF 60mm Culture Dish ASTEC CO.,LTD. PUD 2024-08-01 24580647510051 ASTEC IVF 4Well Dish ASTEC CO.,LTD. PUD 2024-08-01 24580647510068 ASTEC IVF 4Well Dish ASTEC CO.,LTD. PUD 2024-08-01 24580647510075 ASTEC IVF Center Well Dish ASTEC CO.,LTD. PUD 2024-08-01 24580647510082 ASTEC IVF ICSI Dish ASTEC CO.,LTD. PUD 2024-08-01