FDA.report

Metiec

Primary DI
16975737430028
Brand
Metiec
Company
Wuhan Huchuang Union Technology Co., Ltd.
Model
MC2001 10pcs/bag
Published
2022-09-21
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

Related Records

Product Codes

CodeName
PUDLabware, Assisted Reproduction, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUDLabware, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16975737430028PrimaryGS10
06975737430021Unit of UseGS10

GMDN Terms

TermDefinition
Assisted reproduction procedure dishA container intended 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. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
554404052
Device count
200
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
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 DIBrandModelCatalogPublished
06975737430113MetiecD-CK10002024-05-27
06975737430120MetiecTLS3012024-05-27
06975737430106MetiecMC2004 1pc/bag2024-05-27
26975737430001MetiecMC2004 1pc/bag2024-05-27
16975737430004MetiecMC2002 10pcs/bag2022-09-21
16975737430011MetiecMC2011 10pcs/bag2022-09-21
16975737430035MetiecMC2015 10pcs/bag2022-09-21
16975737430042MetiecMC2006 10pcs/bag2022-09-21
16975737430059MetiecMC2007 10pcs/bag2022-09-21
16975737430066MetiecMC2010 10pcs/bag2022-09-21
16975737430073MetiecMC2008 10pcs/bag2022-09-21
16975737430080MetiecMC2003 10pcs/bag2022-09-21
16975737430097MetiecMC2014 10pcs/bag2022-09-21

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
B6861PLSS01SRS01000000ProteX Safe-SealReproductive SolutionsPUD2023-08-23
B68620011ProteXReproductive SolutionsPUD2023-08-02