FDA.reportPublic FDA data

ProteX

Primary DI
B68620011
Brand
ProteX
Company
Reproductive Solutions
Model
1
Catalog number
20001
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. Case of 25 units.
Published
2023-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUDLabware, Assisted Reproduction, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUDLabware, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B686200011PrimaryHIBCC0
B68620011Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Semen specimen collection containerA 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
Ethylene Oxide
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
8004650368Support@reproductive.solutions

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
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B686100SB01SRS0300000NovoSort1100SB01SRS0300002023-08-23
B686100SB01SRS030000NovoSort1100SB01SRS0300002023-08-23
B6861PLSS01SRS01000000ProteX Safe-Seal11PLSS25SRS0100002023-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850068289448SFG 35mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289455SFG 60mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289462SFG 100mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289479SFG ICSI dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289486SFG Center well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289493SFG 4 well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289509SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289516SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289523SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289530SFG Sperm Collection ContainerSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
24580647510051ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
24580647510068ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
24580647510075ASTEC IVF Center Well DishASTEC CO.,LTD.PUD2024-08-01
24580647510082ASTEC IVF ICSI DishASTEC CO.,LTD.PUD2024-08-01
24580647510099ASTEC IVF 35mm Culture DishASTEC CO.,LTD.PUD2024-08-01
24580647510105ASTEC IVF 60mm Culture DishASTEC CO.,LTD.PUD2024-08-01
04582231462186Kitazato ReproPlate-K2KITAZATO CORPORATIONPUD2023-09-01
04582231462193Kitazato ReproPlate-K6KITAZATO CORPORATIONPUD2023-09-01
04582231462209Kitazato ReproPlate-K3KITAZATO CORPORATIONPUD2023-09-01
04582231462407Kitazato ReproPlate-K1(3Well)KITAZATO CORPORATIONPUD2023-09-01
04582231462414Kitazato ReproPlate-K2KITAZATO CORPORATIONPUD2023-09-01
04582231462421Kitazato ReproPlate-K6KITAZATO CORPORATIONPUD2023-09-01
04582231462438Kitazato ReproPlate-K3KITAZATO CORPORATIONPUD2023-09-01
04582231462711Kitazato ReproPlate-K1(3Well)KITAZATO CORPORATIONPUD2023-09-01
B686100SB01SRS0300000NovoSortReproductive SolutionsPUD2023-08-23
B686100SB01SRS030000NovoSortReproductive SolutionsPUD2023-08-23
B6861PLSS01SRS01000000ProteX Safe-SealReproductive SolutionsPUD2023-08-23
06971982050526VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdPUD2022-12-21
06971982050533VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdPUD2022-12-21
06971982050540VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdPUD2022-12-21