FDA.reportPublic FDA data

SFG Sperm CD

Primary DI
10850068289506
Brand
SFG Sperm CD
Company
SPECTRUM FERTILITY GROUP INC.
Model
S-D-SS1
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10850068289506PrimaryGS10
00850068289509Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006828950610850068289506
00850068289509008500682895098500682895090850068289509

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Regulatory Flags#

DUNS number
119292307
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
00850068289530SFG Sperm Collection ContainerSPECTRUM 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