FDA.reportPublic FDA data

SFG Sperm Collection Container

Primary DI
00850068289530
Brand
SFG Sperm Collection Container
Company
SPECTRUM FERTILITY GROUP INC.
Model
S-D-SC
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
10850068289537PrimaryGS10
00850068289530Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006828953710850068289537
00850068289530008500682895308500682895300850068289530

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

Regulatory Flags#

DUNS number
119292307
Device count
150
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850068289001SFG Denuding pipettesS-P-D1302024-11-12
10850068289018SFG Denuding pipettesS-P-D1402024-11-12
10850068289025SFG Denuding pipettesS-P-D1502024-11-12
10850068289032SFG Denuding pipettesS-P-D1602024-11-12
10850068289049SFG Denuding pipettesS-P-D1702024-11-12
10850068289056SFG Denuding pipettesS-P-D1802024-11-12
10850068289063SFG Denuding pipettesS-P-D1902024-11-12
10850068289070SFG Denuding pipettesS-P-D2102024-11-12
10850068289087SFG Denuding pipettesS-P-D2302024-11-12
10850068289094SFG Denuding pipettesS-P-D2502024-11-12
10850068289100SFG Denuding pipettesS-P-D2702024-11-12
10850068289117SFG Denuding pipettesS-P-D2902024-11-12
10850068289124SFG ICSI pipettesS-P-I40.302024-11-12
10850068289131SFG ICSI pipettesS-P-I45.302024-11-12
10850068289148SFG ICSI pipettesS-P-I50.302024-11-12
10850068289155SFG ICSI pipettesS-P-I40.352024-11-12
10850068289162SFG ICSI pipettesS-P-I45.352024-11-12
10850068289179SFG ICSI pipettesS-P-I50.352024-11-12
10850068289186SFG Holding pipettesS-P-H100M.302024-11-12
10850068289193SFG Holding pipettesS-P-H120M.302024-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850068289445SFG 35mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289452SFG 60mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289469SFG 100mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289476SFG ICSI dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289483SFG Center well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289490SFG 4 well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289506SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289513SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289520SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289537SFG Sperm Collection ContainerSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
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
14580647510054ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
14580647510061ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
14580647510078ASTEC IVF Center Well DishASTEC CO.,LTD.PUD2024-08-01
14580647510085ASTEC IVF ICSI DishASTEC CO.,LTD.PUD2024-08-01
14580647510092ASTEC IVF 35mm Culture DishASTEC CO.,LTD.PUD2024-08-01
14580647510108ASTEC IVF 60mm Culture DishASTEC CO.,LTD.PUD2024-08-01
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