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 EUDAMEDAIRSEAL 5 MM ACCESS PORT AND LOW PROFILE OBTURATOR WITH BLADELESS OPTICAL TIP, 120 MM LENGTH FDA UDI
- Model / Reference
- IAS5-120LP EUDAMEDFDA UDI
- Description
- AIRSEAL 5 MM ACCESS PORT AND LOW PROFILE OBTURATOR WITH BLADELESS OPTICAL TIP, 120 MM LENGTH FDA UDI
Identifiers
- Catalog Number
- IAS5-120LP FDA UDI
- Primary DI / UDI-DI
- 10845854045657 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854045657 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 EUDAMEDClass 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
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDILength — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 7e6de69e-0286-48f5-b188-8cdce7635b75 38 fields · synced Oct 7, 2026
- EUDAMED 511fab13-e379-4aa6-94d9-4ddbf174c9bb 61 fields · synced Aug 1, 2026