K-Pack II Needle 27 GA x 0.75" T.W. (0, 4 x 20mm)

FDA UDI

Class I (US FDA UDI)

by Merz North America, Inc.

Identity

Trade Name: K-Pack II Needle 27 GA x 0.75" T.W. (0,4 x 20mm) FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Model / Reference: 9022M1X20 FDA UDI

Identifiers

Primary DI / UDI-DI: M2139022M1X205 FDA UDI
FDA Product Code: GAA FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Hypodermic needle, single-use

K-Pack II Needle 27 GA x 0.75" T.W. (0, 4 x 20mm) by Merz North America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Merz North America, Inc.

Sources (1)

FDA UDI 86435b9b-f2d4-43a8-8753-65e68f17b940 32 fields · synced Jun 9, 2026