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Pa 11

FDA UDI

Class III (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
PA 11 FDA UDI
Generic Name
Cardiac pulse generator analyser cable, single-use FDA UDI
Model / Reference
398789 FDA UDI

Identifiers

Catalog Number
398789 FDA UDI
Primary DI / UDI-DI
04035479135850 FDA UDI
PMA Number
P980023 FDA UDI
FDA Product Code
NVY FDA UDI
GMDN Term
Cardiac pulse generator analyser cable, single-use FDA UDI

Classification

Device Class
Class III 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: Cardiac pulse generator analyser cable, single-use

Pa 11 by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac pulse generator analyser cable, single-use.

Cleared under the same submission

P980023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BIOTRONIK SE & Co. KG

Sources (1)

  • FDA UDI 98e01d9b-fd14-492b-90f7-114fe7f3ac7e 36 fields · synced Jun 7, 2026