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Assi

FDA UDI

Class I (US FDA UDI)

by Accurate Surgical & Scientific Instruments Corp.

Identity

Trade Name
ASSI FDA UDI
Generic Name
Otologic clamp FDA UDI
Device Name
Ear Lobe Clamp for repair of torn or stretched ear lobe pierces FDA UDI
Model / Reference
ASSI.25126 FDA UDI
Description
Ear Lobe Clamp for repair of torn or stretched ear lobe pierces FDA UDI

Identifiers

Primary DI / UDI-DI
00841645120070 FDA UDI
FDA Product Code
HNR FDA UDI
GMDN Term
Otologic clamp FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Otologic clamp

Assi by Accurate Surgical & Scientific Instruments Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Otologic clamp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accurate Surgical & Scientific Instruments Corp.

Sources (1)

  • FDA UDI df16eed1-2b4c-4dc6-a966-c3fda60cbf2d 33 fields · synced Jun 1, 2026