Home GUDID B686100SB01SRS030000 NovoSort
Primary DI B686100SB01SRS030000
Brand NovoSort
Company Reproductive Solutions
Model 1
Catalog number 100SB01SRS030000
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 NovoSort is a component designed to facilitate isolation of sperm while in the ProteX. Case of 25
Published 2023-08-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 B686100SB10SRS030000 Primary HIBCC 0 B686100SB25SRS0300001 Primary HIBCC 0 B686100SB01SRS030000 Unit of Use 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.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 118022050 Device count 25 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B6861PLSS01SRS01000000 ProteX Safe-Seal 1 1PLSS25SRS010000 2023-08-23 B68620011 ProteX 1 20001 2023-08-02
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