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Airseal

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref IAS12-120LPI

by Conmed Corporation

Identity

Trade Name
AIRSEAL EUDAMEDFDA UDI
Generic Name
Laparoscopic access cannula, single-use FDA UDI
Device Name
Non-orthopedic, Non-active, Instrument, Guide/Access, AirSeal EUDAMED
AIRSEAL 12 MM ACCESS PORT AND PALM GRIP OBTURATOR WITH BLADELESS OPTICAL TIP, 120 MM LENGTH FDA UDI
Model / Reference
IAS12-120LPI EUDAMEDFDA UDI
Description
AIRSEAL 12 MM ACCESS PORT AND PALM GRIP OBTURATOR WITH BLADELESS OPTICAL TIP, 120 MM LENGTH FDA UDI

Identifiers

Catalog Number
IAS12-120LPI FDA UDI
Primary DI / UDI-DI
10845854045688 EUDAMEDFDA UDI
Basic UDI-DI
B-10845854045688 EUDAMED
510(k) Number
K230239 FDA UDI
FDA Product Code
GCJ FDA UDI
EMDN Code
Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED
GMDN Term
Laparoscopic access cannula, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 120 Millimeter FDA UDI

Airseal by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K230239 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation

Sources (2)

  • FDA UDI d16fb356-b886-46ac-99c3-0ae07d5d435c 37 fields · synced Oct 7, 2026
  • EUDAMED 6e1286e2-e644-4653-b1c6-3a96eda643f1 61 fields · synced Jul 11, 2026