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AincA®

FDA UDI

Class II (US FDA UDI)

by Anesthesia Associates, Inc.

Identity

Trade Name
AincA® FDA UDI
Generic Name
Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Device Name
Ball Electrode set, (2) Balls x 4mmM Ends, fits 00-100-PLUS Peripheral Nerve Stimulator FDA UDI
Model / Reference
00-106 FDA UDI
Description
Ball Electrode set, (2) Balls x 4mmM Ends, fits 00-100-PLUS Peripheral Nerve Stimulator FDA UDI

Identifiers

Catalog Number
00-106 FDA UDI
Primary DI / UDI-DI
B005001060 FDA UDI
510(k) Number
K811614 FDA UDI
FDA Product Code
BXN FDA UDI
GMDN Term
Block-monitoring peripheral nerve electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2775 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Block-monitoring peripheral nerve electrical stimulation system

AincA® by Anesthesia Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Block-monitoring peripheral nerve electrical stimulation system.

Cleared under the same submission

K811614 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anesthesia Associates, Inc.

Sources (1)

  • FDA UDI 01827307-2932-4a9d-ad8f-314198bdc2dc 36 fields · synced May 30, 2026