FDA.report

ProteX Safe-Seal

Primary DI
B6861PLSS01SRS01000000
Brand
ProteX Safe-Seal
Company
Reproductive Solutions
Model
1
Catalog number
1PLSS25SRS010000
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 device includes a component to the lid designed to stabilize the sample during transport. 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

Related Records

Contact Domains

Product Codes

CodeName
PUDLabware, Assisted Reproduction, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUDLabware, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6861PLSS25SRS0100000PrimaryHIBCC0
B6861PLSS01SRS01000000Unit of UseHIBCC0

GMDN Terms

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

Contacts

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
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 DIBrandModelCatalogPublished
B6861PC0010SRS010000ProteX11PC0010SRS0100002024-02-01
B686100SB01SRS0300000NovoSort1100SB01SRS0300002023-08-23
B686100SB01SRS030000NovoSort1100SB01SRS0300002023-08-23
B6861PLSS01SRS0100000ProteX Safe-Seal11PLSS01SRS0100002023-08-23
B68620011ProteX1200012023-08-02
B686100010ProteX1100012023-03-29

Other Devices Sharing Product Codes

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
B6861PC0010SRS010000ProteXReproductive SolutionsPUD2024-02-01
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
B6861PLSS01SRS0100000ProteX Safe-SealReproductive SolutionsPUD2023-08-23
B68620011ProteXReproductive SolutionsPUD2023-08-02
B686100010ProteXReproductive SolutionsPUD2023-03-29