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Internal Paddle Handle

FDA UDI

Class III (US FDA UDI)

by PHYSIO-CONTROL, Inc.

Identity

Trade Name
Internal Paddle Handle FDA UDI
Generic Name
Internal defibrillation electrode, adult, reusable FDA UDI
Device Name
ASSY, PADDLE, INTERNAL HANDLE, WITH UDI FDA UDI
Model / Reference
11131 FDA UDI
Description
ASSY, PADDLE, INTERNAL HANDLE, WITH UDI FDA UDI

Identifiers

Catalog Number
11131-000001 FDA UDI
Primary DI / UDI-DI
00681490583275 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Internal defibrillation electrode, adult, reusable FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 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

No

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Internal defibrillation electrode, adult, reusable

Internal Paddle Handle by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal defibrillation electrode, adult, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PHYSIO-CONTROL, Inc.

Sources (1)

  • FDA UDI 33a73e7c-9d30-4992-a930-57cde327e122 35 fields · synced Jun 9, 2026