FDA.reportPublic FDA data

Metiec

Primary DI
06975737430120
Brand
Metiec
Company
Wuhan Huchuang Union Technology Co., Ltd.
Model
TLS301
Published
2024-05-27
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
MTXMicroscope And Microscope Accessories, Reproduction, Assisted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTXMicroscope And Microscope Accessories, Reproduction, AssistedObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232493000Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.2024-05-07MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975737430120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975737430120069757374301206975737430120

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554404052
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16975737430110MetiecMC2004 1pc/bag2024-05-27
06975737430113MetiecD-CK10002024-05-27
06975737430106MetiecMC2004 1pc/bag2024-05-27
26975737430001MetiecMC2004 1pc/bag2024-05-27
16975737430004MetiecMC2002 10pcs/bag2022-09-21
16975737430011MetiecMC2011 10pcs/bag2022-09-21
16975737430028MetiecMC2001 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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909262200156Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-05-19
00664816005316LW Scientific, Inc.LW SCIENTIFIC, INC.MTX2026-04-17
00664816005323LW Scientific, Inc.LW SCIENTIFIC, INC.MTX2026-04-17
04582754071520IX73 2PORT FRAMEEVIDENT CORPORATIONMTX2025-10-31
04582754071674TRANSMITTED ILLUMINATOREVIDENT CORPORATIONMTX2025-10-31
04582754073340CONTROL BOX MEVIDENT CORPORATIONMTX2025-10-31
04582754073357HAND SWITCHEVIDENT CORPORATIONMTX2025-10-31
04582754073364LED POWER SUPPLYEVIDENT CORPORATIONMTX2025-10-31
04582754073371EYEPIECEEVIDENT CORPORATIONMTX2025-10-31
04582754073388EYEPIECEEVIDENT CORPORATIONMTX2025-10-31
04582754073609UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2025-10-31
04582754073838UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2025-10-31
04582754074095UIS2 OBJECTIVE LENS FOR BIOLOGYEVIDENT CORPORATIONMTX2025-10-31
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MTX2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MTX2025-09-30
04582754070608100W HALOGEN LAMP HOUSINGEVIDENT CORPORATIONMTX2025-07-25
04582754070639EXTENSION CORDEVIDENT CORPORATIONMTX2025-07-25
04549921600341ECLIPSE Ti2-I USNIKON CORPORATIONMTX2025-07-01
04582643159520UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2024-05-10
04582643149095UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2023-07-31
04064897000006Zeiss Stemi 508Carl Zeiss Microscopy GmbHMTX2022-09-28
04064897000013Zeiss Stemi 508Carl Zeiss Microscopy GmbHMTX2022-09-28
04064897000020Zeiss Stemi 508Carl Zeiss Microscopy GmbHMTX2022-09-28
04064897000037Zeiss SteREO DiscoveryCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000044Zeiss SteREO DiscoveryCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000051Zeiss SteREO DiscoveryCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000068Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000075Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000082Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
0458264313002412 V, 100 W LONG-LIFE HALOGEN BULBEVIDENT CORPORATIONMTX2022-04-11