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Solox SLX 58/13-BP

FDA UDI

Class III (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
Solox SLX 58/13-BP FDA UDI
Generic Name
Endocardial/interventricular septal pacing lead FDA UDI
Model / Reference
333900 FDA UDI

Identifiers

Catalog Number
333900 FDA UDI
Primary DI / UDI-DI
04035479049218 FDA UDI
PMA Number
P950037 FDA UDI
FDA Product Code
DTB FDA UDI
GMDN Term
Endocardial/interventricular septal pacing lead FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.3680 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Solox SLX 58/13-BP by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P950037 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 87d2515d-3ce5-4c36-9324-170f4fd04fb3 38 fields · synced Jun 8, 2026