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Follicle Aspiration Set Double Lumen

FDA UDI

Class II (US FDA UDI)

by Vitrolife Sweden AB

Identity

Trade Name
Follicle Aspiration Set Double Lumen FDA UDI
Generic Name
IVF oocyte aspiration needle, single-use FDA UDI
Model / Reference
17129 FDA UDI

Identifiers

Primary DI / UDI-DI
07350025915234 FDA UDI
510(k) Number
K161970 FDA UDI
FDA Product Code
MQE FDA UDI
GMDN Term
IVF oocyte aspiration needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6100 FDA UDI
Commercial Distribution
Not 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

Follicle Aspiration Set Double Lumen by Vitrolife Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K161970 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vitrolife Sweden AB

Sources (1)

  • FDA UDI 63ba9e90-1592-4c01-85fe-ad40e9dc9f25 34 fields · synced Jun 1, 2026