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Zoellner Micro Ear Needle

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
ZOELLNER MICRO EAR NEEDLE FDA UDI
Generic Name
General-purpose endoscopic needle, reusable FDA UDI
Device Name
ZOELLNER MICRO EAR NEEDLE STRAIGHT SHARP TIP FDA UDI
Model / Reference
68-1150 FDA UDI
Description
ZOELLNER MICRO EAR NEEDLE STRAIGHT SHARP TIP FDA UDI

Identifiers

Catalog Number
68-1150 FDA UDI
Primary DI / UDI-DI
00192896020061 FDA UDI
FDA Product Code
GDM FDA UDI
GMDN Term
General-purpose endoscopic needle, reusable 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-purpose endoscopic needle, reusable

Zoellner Micro Ear Needle by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose endoscopic needle, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI ae78d929-f00c-4d06-b387-2029fef39d47 35 fields · synced Jun 8, 2026