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Enhance Sperm Wash with Gentamicin

FDA UDI

Class II (US FDA UDI)

by Vitrolife AB

Identity

Trade Name
Enhance Sperm Wash with Gentamicin FDA UDI
Generic Name
Spermatozoa/semen motility medium supplement FDA UDI
Device Name
12-(12ml) Sperm Wash Modified HTF Medium w/Gentamicin FDA UDI
Model / Reference
15262 FDA UDI
Description
12-(12ml) Sperm Wash Modified HTF Medium w/Gentamicin FDA UDI

Identifiers

Primary DI / UDI-DI
10805360016855 FDA UDI
510(k) Number
K023717 FDA UDI
FDA Product Code
MQL FDA UDI
GMDN Term
Spermatozoa/semen motility medium supplement FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6180 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

Dimensions & Sizes

Size
Total Volume — 12 Milliliter FDA UDI

Category: Spermatozoa/semen motility medium supplement

Enhance Sperm Wash with Gentamicin by Vitrolife AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spermatozoa/semen motility medium supplement.

Cleared under the same submission

K023717 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vitrolife AB

Sources (1)

  • FDA UDI 481014e3-6472-4706-9a28-6cd38e3920b0 35 fields · synced May 31, 2026