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Injection Needle

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Injection Needle FDA UDI
Generic Name
Submucosal injection needle FDA UDI
Device Name
POM inner tuber,Needle Length 5mm,with metal cap 25G*5*2.3*200,Shroat stucture FDA UDI
Model / Reference
IN12-255232002 FDA UDI
Description
POM inner tuber,Needle Length 5mm,with metal cap 25G*5*2.3*200,Shroat stucture FDA UDI

Identifiers

Catalog Number
IN12-255232002 FDA UDI
Primary DI / UDI-DI
06932503533232 FDA UDI
510(k) Number
K150434 FDA UDI
FDA Product Code
FBK FDA UDI
GMDN Term
Submucosal injection needle 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

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
Length — 200 Centimeter FDA UDI
Needle Gauge — 25 Gauge FDA UDI

Category: Submucosal injection needle

Injection Needle by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Submucosal injection needle.

Cleared under the same submission

K150434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA UDI 709d65d7-1e8b-4d26-bc83-0e864bc8d087 37 fields · synced May 30, 2026