FDA.report

Metiec

Primary DI
06975737430120
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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
554404052
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
06975737430120PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
06975737430120PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Obstetrics/Gynecology884.6190NEligible

Premarket Submissions

SubmissionSupplement
K232493000

Premarket Details

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

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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

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