injeTAK Adjustable Tip Needle 35cm

FDA UDIEUDAMED

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name: injeTAK Adjustable Tip Needle 35cm FDA UDI
Generic Name: General-purpose endoscopic needle, single-use FDA UDI
Model / Reference: DIS199 FDA UDI

Identifiers

Primary DI / UDI-DI: 00627825000017 FDA UDI
510(k) Number: K090830 FDA UDI
FDA Product Code: FBK FDA UDI
GMDN Term: General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: General-purpose endoscopic needle, single-use

injeTAK Adjustable Tip Needle 35cm by Laborie Medical Technologies Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Also classified as General-purpose endoscopic needle, single-use.

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Injectra, ScleroTip — Medi-Globe Corporation · Class II
Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
Henry Schein — HENRY SCHEIN, INC. · Class I

Cleared under the same submission

K090830 also covers:

injeTAK Adjustable Tip Needle 70cm — Laborie Medical Technologies Canada ULC

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Laborie Medical Technologies Canada ULC

Sources (2)

FDA UDI 07b99dbb-abfb-4893-bf24-b8ffa075ccb4 33 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 2, 2026