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S 60-J

FDA UDI

Class II (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
S 60-J FDA UDI
Generic Name
Vascular catheter stylet FDA UDI
Model / Reference
106164 FDA UDI

Identifiers

Catalog Number
106164 FDA UDI
Primary DI / UDI-DI
04035479145064 FDA UDI
PMA Number
P820076 FDA UDI
510(k) Number
K191469 FDA UDI
FDA Product Code
DRB FDA UDI
GMDN Term
Vascular catheter stylet FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1380 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: Vascular catheter stylet

S 60-J by BIOTRONIK SE & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter stylet.

Cleared under the same submission

K191469 also covers:

P820076 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 e288ae80-0fab-454a-abda-943e2cfe7787 36 fields · synced May 30, 2026