FDA.reportPublic FDA data

ASTEC IVF 4Well Dish

Primary DI
14580647510061
Brand
ASTEC IVF 4Well Dish
Company
ASTEC CO.,LTD.
Model
AID-4WH
Published
2024-08-01
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
24580647510068PackageGS130In Commercial Distribution
14580647510061PrimaryGS10
04580647510064Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2458064751006824580647510068
1458064751006114580647510061
04580647510064045806475100644580647510064

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
694169152
Device count
4
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
04580647510125EC10-120MDEC10-120MD2026-01-12
14580647510054ASTEC IVF 4Well DishAID-4W2024-08-01
14580647510078ASTEC IVF Center Well DishAID-CW2024-08-01
14580647510085ASTEC IVF ICSI DishAID-ICSI2024-08-01
14580647510092ASTEC IVF 35mm Culture DishAID-352024-08-01
14580647510108ASTEC IVF 60mm Culture DishAID-602024-08-01
24580647510051ASTEC IVF 4Well DishAID-4W2024-08-01
24580647510068ASTEC IVF 4Well DishAID-4WH2024-08-01
24580647510075ASTEC IVF Center Well DishAID-CW2024-08-01
24580647510082ASTEC IVF ICSI DishAID-ICSI2024-08-01
24580647510099ASTEC IVF 35mm Culture DishAID-352024-08-01
24580647510105ASTEC IVF 60mm Culture DishAID-602024-08-01
04580647510033Embryo GridAID-0125M2022-10-01
14580647510030Embryo GridAID-0125M2022-10-01
04580647510026Dry IncubatorEC6S-120MD2019-07-17

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
00850068289530SFG Sperm Collection ContainerSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
14580647510054ASTEC 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