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Embryo transfer catheter

FDA UDI

Class II (US FDA UDI)

by Gynetics Medical Products NV

Identity

Trade Name
Embryo transfer catheter FDA UDI
Generic Name
Assisted reproduction catheter set FDA UDI
Device Name
Embryo transfer catheter used for introduction of embryos into the uterine cavity. FDA UDI
Model / Reference
#4219 Emtrac Set FDA UDI
Description
Embryo transfer catheter used for introduction of embryos into the uterine cavity. FDA UDI

Identifiers

Primary DI / UDI-DI
05425017501053 FDA UDI
510(k) Number
K013536 FDA UDI
FDA Product Code
MQF FDA UDI
GMDN Term
Assisted reproduction catheter set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.20 Milliliter FDA UDI

Category: Assisted reproduction catheter set

Embryo transfer catheter by Gynetics Medical Products NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction catheter set.

Cleared under the same submission

K013536 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gynetics Medical Products NV

Sources (1)

  • FDA UDI c90ee97a-498f-4ca3-860f-9a6bd6be5d46 37 fields · synced May 30, 2026