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Abc D-Flex

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
ABC D-FLEX FDA UDI
Generic Name
Inert gas-enhanced electrosurgical system FDA UDI
Device Name
ABC D-FLEX FLEXIBLE LAPAROSCOPIC PROBE FOR CONMED SYSTEM 7550 AND HELIXAR FDA UDI
Model / Reference
60-8627-001 FDA UDI
Description
ABC D-FLEX FLEXIBLE LAPAROSCOPIC PROBE FOR CONMED SYSTEM 7550 AND HELIXAR FDA UDI

Identifiers

Catalog Number
60-8627-001 FDA UDI
Primary DI / UDI-DI
10653405082507 FDA UDI
510(k) Number
K151229 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Inert gas-enhanced electrosurgical system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

Category: Inert gas-enhanced electrosurgical system

Abc D-Flex by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inert gas-enhanced electrosurgical system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI ca9c8267-16cc-440e-9b40-c068af7660e3 37 fields · synced Jun 8, 2026