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Labotect

FDA UDI

Class II (US FDA UDI)

by Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung

Identity

Trade Name
Labotect FDA UDI
Generic Name
Assisted reproduction needle, single-use FDA UDI
Device Name
Single lumen puncture set with grinded echo marking for aspiration only FDA UDI
Model / Reference
Ovarian Biopsy Set No. 1 FDA UDI
Description
Single lumen puncture set with grinded echo marking for aspiration only FDA UDI

Identifiers

Catalog Number
13440 FDA UDI
Primary DI / UDI-DI
04046668002266 FDA UDI
510(k) Number
K003056 FDA UDI
FDA Product Code
MQE FDA UDI
GMDN Term
Assisted reproduction needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6100 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

No

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

Yes

FDA UDI

Category: Assisted reproduction needle, single-use

Labotect by Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction needle, single-use.

Cleared under the same submission

K003056 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 0973d9aa-15fa-4a41-9b53-b2ed8c0762a8 36 fields · synced Jun 6, 2026