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P.n.s.™

FDA UDI

Class II (US FDA UDI)

by Graphic Controls Acquisition Corp

Identity

Trade Name
P.N.S.™ FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
Dual Electrode 2/POUCH, 50 POUCHES/BOX, 6 BOXES/CASE, 300 electrodes/case FDA UDI
Model / Reference
A10011 FDA UDI
Description
Dual Electrode 2/POUCH, 50 POUCHES/BOX, 6 BOXES/CASE, 300 electrodes/case FDA UDI

Identifiers

Catalog Number
A10011 FDA UDI
Primary DI / UDI-DI
10813150020616 FDA UDI
FDA Product Code
DRX FDA UDI
GMDN Term
Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic electrode, single-use

P.n.s.™ by Graphic Controls Acquisition Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Graphic Controls Acquisition Corp

Sources (1)

  • FDA UDI b6193395-fa4a-4ccc-8473-ad8a401856c6 35 fields · synced Jun 8, 2026